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Did you know about this Philips AED
Recall?
Philips has recently issued a recall on their HeartStart Home and OnSite (HS1) AEDs.
Affected Devices : Serial Number A13G-#####
If you have purchased a Philips device in 2013 or after, please read the information below to see if you are affected. If you are affected contact Philips immediately for a replacement device at 1-800-263-3342 and select OPTION 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message 24 hours a day, seven days a week and a customer support representative will return your call promptly on the next business day.
Read the letter from Philips:
Philips Field Note 2014 FEB 10
Models Affected: M5066A and M5068A. Affected Devices have Serial Number A13G-#####
Problem: Contact pins contaminated preventing a connection from pads cartridge to the AED.
Other AEDs under recall:
| Recall Date: 01/01/2016 |
| Title: 9131-001 Defibrillator Electrodes, Lot No. 141125-02 |
| Units: Powerhear G3 9300A, 9300E, 9300p, 9390A, and 9390E AEDs |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 01/13/2012 |
| Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall. |
| Units: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs) selected Powerheart models, 9300E, 9300P, 9390A, 9390E, 11,000 units worldwide. |
| Issue: Cardiac Science is conducting a voluntary recall of a limited number of automated external defibrillators (AEDs) manufactured between July 1, 2011 and December 30, 2011. The affected AEDs contain a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy. This issue was detected at the Cardiac Science factory through our standard quality control processes. We have no reports of this issue impacting a rescue. This action is being conducted with the knowledge of the appropriate Regulatory Agencies. |
| Fix: enter serial number, if on the list contact Cardiac Science and have repaired at no cost. |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 06/29/2010 |
| Title: Mandatory Software Update for Field Correction: AED resistor and AED relay Does your unit need to have the 11/13/09 corrective action? |
| Fix: enter serial number, if on the list download and install the software update |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/03/2010 |
| Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall |
| Fix: If on the list, remove from service immediately. CS will replace the AED |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 11/13/2009 |
| Title: Voluntary Medical Device Correction: AED resistor and AED relay |
| Fix: Install mandatory software update on all models |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 10/09/2009 |
| Title: Factory-Testing Corrective Action |
| Fix: If on the list, send unit to CS for testing |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 12/03/2014 |
| Title: PadPro and R2 Multi-Function Defibrillation Electrodes because they will not work with Philips FR3 and FRx AEDs. |
| Units:
|
| Issue: Electrodes will not work with Philips FR3 and FRx AEDs. Philips made changes to the connector design of their FR3 and FRx AEDs. Because of these changes, the CONMED electrodes will no longer work with these AEDs. The FRx AED requires electrode pads be connected to the device before it is used. The AED will make a continuous alarm chirp to alert the user that the correct pads are not connected. The FR3 does not require electrode pads to be pre-connected. Users will not know that the pads do not work until they try to use the AED. This may result in a delay in delivering the electrical therapy needed to revive a patient. Delay in therapy could result in serious injury or death. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 03/14/2011 |
| Title: Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock |
| Units: Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. 65,885 AEDs distributed in the United States are subject to this recall. |
| Issue: AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. |
| Fix: Customers can check the nine-digit serial number on the back of their AED against the list published by Defibtech to see if their devices are affected. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 05/21/2010 |
| Title: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED |
| Units: DBP-2800 Battery Pack for the Defibtech ReviveR AED |
| Fix: Contact Defibtech for correction |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 09/12/2012 |
| Title: HeartSine Samaritan 300/300P PAD Voluntary Recall |
| Units: HeartSine Samaritan 300/300P PADs, if your unit was recalled you will have received a letter directly from HeartSine. Units affected are: 0400000501 – 0700032917 08A00035000 – 10A0070753 10C00200000 – 10C00210106 |
| Issue: Off/On issue, battery management software issue. |
| Fix: Contact Think Safe 319-377-5125, 8 AM through 5 PM CST, Monday through Friday |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/16/2018 |
| Title: Field Action for R92 Resistor Issue |
| Units: A limited number of Philips HeartStart Home and OnSite (HS1) and Philips FRx units are affected by this action. Serial numbers of all affected devices. Home/Onsite: A02I-xxxxx – A13B-xxxxx FRx: B04L-xxxxx – B13B-xxxxx |
| Issue: The issue affects certain HS1 (OnSite) and FRx defibrillators, which contain a component called a resistor that, under extremely rare circumstances, may fail when high voltage is applied. In all instances of resistor failure, the AED will initially communicate the failure by emitting a pattern of triple chirps. |
| Fix: If your device is part of this notification and is still under warranty, customers may choose to receive a refurbished exchange unit at no cost If a device is no longer under warranty or if customers wish to purchase a newer model replacement for their present AED. Philips is offering trade-in rebates, ranging from $50 to $625, depending on the age and model of the affected AED. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, customers should contact Think Safe at 888-473-1777. |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/14/2018 |
| Title: HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs Recall |
| Units: Onsite (A13A-xxxxx or A13B-xxxxx) and Frx Automated External Defibrillators (B04L-xxxxx through B13B-xxxxx) |
| Issue: Philips HeartStart FRx, HeartStart OnSite, or HeartStart Home automated external defibrillators (AEDs) manufactured between 2002 and 2013. Philips is voluntarily issuing this recall notification due to awareness of isolated failures with one of the device’s electrical components (a resistor). |
| Fix: Contact Think Safe 319-377-5125, 8 AM through 5 PM CST, Monday through Friday |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/09/2018 |
| Title: HeartStart MRx Defibrillators Recall |
| Units: Model/Item numbers: M3535A, M3536A |
| Issue: Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device’s Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device’s designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.
As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device’s Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 2/14/2014 |
| Title: Feild Safety Notice: Contact Pin Contamination |
| Units: A limited number of Philips HeartStart Home and OnSite (HS1) models M5066A and M5068A are affected by this action. Philips has identified the serial numbers of all affected devices. |
| Issue: In a limited number of HeartStart Home and OnSite (HS1) AEDs, one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. |
| Fix: If you are have an affected device, please contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message 24 hours a day, seven days a week; a customer support representative will return your call promptly on the next business day.Please keep your AED in service until you receive a replacement if there are no alternative defibrillators readily available. |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 12/28/2012 |
| Title: Philips HeartStart FR2+ defibrillator discontinuance |
| Units: FR2+ |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 10/30/2012 |
| Title: AED Maintenance Information |
| Issue: Philips wanted to inform FRx and OnSite HeartStart AED owners of potentially misunderstood alerts from their AEDs. |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 06/02/2010 |
| Title: Voluntary recall: Specific Philips HeartStart HS1 and FRx Defibrillators |
| Units: HS1 (models M5066A and M5068A) and FRx (model 861304) automated external defibrillators. The units affected by the recall were manufactured by Philips in March 2010. |
| Fix: Perform serial number look up on company website, company will direct further if your unit is affected. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 03/20/2020 |
| Title: 2020 Component Wear that prevents patient Connection |
| Units: LIFEPAK 500 |
| Issue: LIFEPAK 500 AEDs in high-use enviroments (Emergency Medical Services) may ot detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. Wear-through of the connector exposes base metal on which an oxide layer may form result in the device not recognizing a patient is connected. When the circumstance arises, the device will provide the user the “CONNECT ELECTRODES” message. |
| Fix: Replace AED with a FDA approved device. |
| Alert Documentation |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 10/27/2017 |
| Title: Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork |
| Units: Model/Item Numbers: 11101-000016 and 11101-000017 Lot codes: 713609, 717912, 713904, 718033, 715008, 719323, 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012 Manufacturing Dates: April 27, 2017 to August 10, 2017 Distribution Dates: May 30, 2017 to September 4, 2017 Devices Recalled in the U.S.: 7,973 units nationwide |
| Issue: Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 01/13/2017 |
| Title: LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment. |
| Units: Lifepak 1000 |
| Issue: LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment. |
| Fix: Customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and the company will contact customers to schedule device corrections once the hardware correction is ready for implementation. The company will provide customers with updated information regarding the timing for this device correction at the website URL shown below, when it is available. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 07/19/2013 |
| Title: 2013 class 2 recall of Lifepak 500 AED (all parties contacted so no remaining devices left to be upgraded) |
| Units: LIFEPAK 500 PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650. |
| Issue: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 04/10/2013 |
| Title: 2013 CR Plus and Express AED recall: (over 130,000 AEDs affected) |
| Units: LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part’s numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. |
| Issue: LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 07/ 26/2011 |
| Title: 2011 Lifepak 500 recall: |
| Units: LIFEPAK 500 |
| Issue: The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 07/31/2009 |
| Title: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs) |
| Units: Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall. Serial Numbers: 37026963, 37026983, 37026984, 37026997, 37027002,37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211, 37038365, 37135986, 37154526, 37154638 |
| Issue: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy. |
| Fix: Contact Physio-Control Customer Care 1-800-442-1142, 6 AM through 4 PM Pacific Time |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 10/30/2008 |
| Title: CR Plus 2008 recall: |
| Units: LIFEPAK CR Plus |
| Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 10/30/2008 |
| Title: 2008 Lifepak Express recall: |
| Units: LIFEPAK Express |
| Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 08/04/2007 |
| Title: Lifepak 500 – 2007 recall |
| Units: biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers) |
| Issue: Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 06/21/2007 |
| Title: CR Plus – 2007 recall |
| Units: LIFEPAK CR Plus |
| Issue: Premature battery depletion due to electrical component failure |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 06/21/2007 |
| Title: Lifepak Express – 2007 recall |
| Units: LIFEPAK EXPRESS defibrillator |
| Issue: Premature battery depletion due to electrical component failure |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 03/29/2007 |
| Title: CR Plus – 2007 (march) recall |
| Units: LIFEPAK CR Plus |
| Issue: LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/23/2006 |
| Title: CR Plus – 2006 recall |
| Units: LIFEPAK CR Plus |
| Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/22/2006 |
| Title: Lifepak 500 – 2006 recall |
| Units: LIFEPAK 500 |
| Issue: Component leads may have intermittent connection to the printed circuit board assembly pads – which could render the device inoperative. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 10/19/2005 |
| Title: Lifepak 500 – 2005 recall (cases) |
| Units: a) Hard shell carry case for the Lifepak 500 AED. Catalog number 3005384-000 through 002, Recall # Z-0004-06; b) Hard shell carry case for the Lifepak CR Plus. Catalog number 3201582-000 through –002, Recall # Z-0005-06 |
| Issue: Some hard shell carry case for Lifepak 500 and Lifepak CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landing or mountain descent). |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 10/04/2005 |
| Title: Lifepak CR Plus – 2005 recall (cases) |
| Units: Hard shell carry case for the LIFEPAK CR Plus. |
| Issue: Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent). |
| Fix: On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 03/10/2005 |
| Title: Lifepak 500 2005 recalls |
| Units: LIFEPAK 500 Serial numbers – various, noncontiguous Part numbers – 3005400-XXX, D3005400-XXX, U3005400-XXX |
| Issue: Potential to not detect patients at the low end of the patient impedance range. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/03/2005 |
| Title: Certain Medtronic LIFEPAK 500 Automated External Defibrillators Class 1 Recall |
| Units: LIFEPAK 500 automated external defibrillators (AEDs), part numbers 3005400-XXX, D3005400-XXX and U3005400-XXX. This action affects 1,924 devices. All were manufactured in 1997. |
| Issue: The affected AEDs may display a “Connect Electrodes” message and then will not defibrillate the patient, even when the electrodes are properly connected. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 07/20/2004 |
| Title: Lifepak 500 – 2004 recalls |
| Units: LIFEPAK 500 |
| Issue: Potential for batteries to malfunction due to battery cell rupture. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 06/12/2003 |
| Title: Lifepak CR Plus – 2003 recall |
| Units: LIFEPAK CR Plus All serial numbers below 31058753 |
| Issue: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: |
| Title: Lifepak Express – 2006 recall |
| Units: LIFEPAK EXPRESS Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus |
| Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative. |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: |
| Title: 2008 CR Plus recall: |
| Units: LIFEPAK CR Plus |
| Issue: This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. |
| Need help with recalls for your device? Contact Think Safe! |
| Title: Welch Allyn AED 10 Recall Information |
| Units: Welch Allyn AED10 or MRL JumpStart defibrillator * Part numbers 970300x, 970302x, 970308x, 970309x, 970310x, 970311x, where “x” specifies the language as English, Dutch, Danish, Chinese, French, German, Italian, Polish, Spanish, or European English |
| Issue: Low Energy Shock, Electromagnetic Noise Interference, Unexpected Shutdown During Use, Blown Fuse, Loss of Voice Prompts Shutdown in Cold Temperatures |
| Fix: Contact Think-Safe (888)473-1777 |
| Need help with recalls for your device? Contact Think Safe! |
| Recall Date: 02/12/2009 |
| Title: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator, Class 1 Recall |
| Units: ZOLL AED Plus Defibrillator, Class 1 Recall Units Recalled: This product was manufactured from May, 2004 through February, 2009 and distributed from May, 2004 through February 9, 2009. |
| Issue: The AED failed to deliver the defibrillation energy. |
| Fix: The company sent their distributors and customers an initial recall letter on February 12, 2009 by certified mail. This letter instructed customers to replace their batteries every three years. The company then sent their distributors and customers a follow-up recall letter on March 31, 2009 by certified mail. This letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels. |
| Need help with recalls for your device? Contact Think Safe! |
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