Recalls:Update vs. Replace - Go Green. Get AED Recalls & Updates
Don't let your AED become out of date from American Heart Association (AHA) guidelines. AEDs are designed to be updated. Also, all major AED manufacturers and their models have had software or hardware upgrades through FDA field corrective actions or FDA equipment recall notices. Extend the life of your AED as much as possible through our comprehensive database of AED recalls and updates available (most of which are free).
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.
Title: Mandatory Software Update for Field Correction: AED resistor and AED relay Does your unit need to have the 11/13/09 corrective action?
Title: PadPro and R2 Multi-Function Defibrillation Electrodes because they will not work with Philips FR3 and FRx AEDs.
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.
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.
Units: HeartSine Samaritan 300/300P PADs, if your unit was recalled you will have received a letter directly from HeartSine.
Units affected are:
08A00035000 - 10A0070753
10C00200000 - 10C00210106
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.
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).
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.
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.
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.
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.
Title: LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.
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.
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.
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.
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.
Units: Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
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.
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.
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.
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).
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.
Units: LIFEPAK 500
Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX
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.
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.
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.
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
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.
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.