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AED Recalls
Thousands of AEDs Recalled in 2007 - Read RASMAS' Updated AED Recall List
After noting the unusually high number of AED recalls in the last few years, RASMAS analysts compiled a list of recalled devices and are making this recall information available to the public.
| Table 1. Automated External Defibrillator (AED) Recalls | |||||
| Date | Alert ID # | Manufacturer | Device | Quantity | Reason |
| 12/28/2007 |
#2007120813 | Manufactured by Nordix, Inc. for BatteryZone, Inc.; Cardiac Science Corporation | life+cel, Replacement Batteries for Cardiac Science: Powerheart AED and FirstSave SurvivaLink | 142 | Alert Update: Adds Additional Product
Descriptions and Model/Product Numbers to Alert #2007120715 of
12/21/2007. Marketed without 510 (K) approval. |
| 11/13/2007 |
#2007110586 URGENT | Welch Allyn Protocol, Inc. | Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator | 1,795 | Alert Update: Specifies Serial Numbers for Alert #2007110221 of 11/05/2007. Failure to Deliver Shock: A defective capacitor may cause the delay or non-delivery of the defibrillating shock |
| 09/25/2007 |
#2007090301 URGENT |
Welch Allyn Protocol, Inc. | Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator | 1,637 | Alert Update: Specifies Serial Numbers for Alert #2007090276 of 09/20/2007 Failure to Deliver Therapy: May display a "Defib Comm" error message during use which may result in failure to analyze the patient's ECG and deliver the appropriate therapy. |
| 07/10/2007 |
#2007070085 | Medtronic Emergency Response Systems, Inc. | LIFEPAK 20 defibrillator/monitor and batteries used with the LIFEPAK 20 defibrillator/monitor | 26,418 units and 3,002 batteries | Internal battery cell may contain a short that shuts down the device while operating on backup (DC) battery power. |
| 06/27/2007 |
2007060265 | Medtronic Emergency Response Systems, Inc. | LIFEPAK CR Plus and EXPRESS Defibrillators | 14,693 | Premature battery depletion due to electrical component failure. |
| 06/14/2007 |
2007060115 | Medtronic Emergency Response Systems, Inc. | LIFEPAK 20 Defibrillator/Monitor | 859 | White Screen Lock Up: Device lock up may cause a delay or prevention of shock treatment. |
| 04/05/2007 |
2007040070 | Medtronic Emergency Response Systems, Inc. | LIFEPAK CR Plus Defibrillators | 13,835 | Alert Update: Adds additional Model/Product numbers
and Stock Identifiers for Alert #2007030430 of 03/30/2007. May falsely indicate that the battery needs to be replaced. |
| 03/28/2007 |
2007030409 | Philips Medical Systems | Philips HeartStart FR2+ Defibrillators Automated External Defibrillator (AED) | 9,099 | Alert Update: Specifies additional Model/Product Number
and Stock Identifiers for Alert #2007010001 of 01/02/2007. Board contamination may cause shock treatment to be delayed or prevented. |
| 03/13/2007 | 2007030190 URGENT | Defibtech, LLC | Defibtech Sentry Semi-Automatic External Defibrillators sold as "Lifeline AED" brand and "ReviveR AED" brand. | 42,650 | Alert Update: Specifies Product IDs for Alert
#2007030090 of 03/07/2007. Device Malfunction—Self-test software may clear a previously detected low battery condition and the device may be unable to deliver a defibrillation shock. |
| 01/02/2007 |
2007010001 | Philips Medical Systems | Philips/Laerdal HeartStart FR2+ Automated External Defibrillator | 2,000 | Board contamination may cause shock treatment to be delayed or prevented. |
| 12/18/2006 |
2006120277 | Medtronic Emergency Response Systems, Inc. | LIFEPAK 20 Defibrillators/Monitors; Software versions: 28, 30, 32, 38 | 460 | Device may lock-up and cause an unacceptable delay in the delivery of a defibrillating shock. |
| 12/01/2006 |
2006120002 | Medical Research Lab; Distributor: Welch Allyn Protocol, Inc. | Welch Allyn Portable Intensive Care (PIC) 50 System: Portable monitor/defibrillator | Not Specified | Error message may prevent or unacceptably delay delivery of defibrillation shock. |
| 11/08/2006 |
2006110172 | Medtronic Emergency Response Systems, Inc. | LIFEPAK 20 external defibrillator/monitor | 3,141 | Devices with v38 system software do not display a "LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC) battery power and may shut down without warning. |
| 07/14/2006 |
2006070222 URGENT |
MRL Inc., A Welch Allyn Company | Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator | 1,184 | Alert Update: Specifies Part Numbers for RASMAS Alert #2006070091 of 07/07/2006. May display a "Defib Comm" or "'Pace Comm" error message during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy. |
| 06/28/06 |
2006060370 URGENT |
MRL, Inc., A Welch Allyn Company | Welch Allyn AED 20 Automated External Defibrillator | 580 | Alert Update: Specifies Serial & Catalog Numbers for RASMAS Alert #2006060209 of 06/27/2006. May display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy. |
| 04/04/06 |
2006040030 | Medtronic Emergency Response Systems, Inc. | LIFEPAK 12 and Lifepak 20 Defibrillator/Monitor | 3,620 | Alert Update: Specifies Serial Numbers for RASMAS Alert #2006030592 of 03/31/06. Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. |
| 02/24/06 |
2006020403 | Medtronic Emergency Response Systems, Inc. | LIFEPAK CR Plus and LIFEPAK Express AED | 20,525 | One of the printed circuit board assemblies (PCBA) may be contaminated with solder flux which can cause a short and render device inoperative. |
| 02/22/06 |
2006020329 | Cardiac Science, Inc. | Powerheart AED G3 Automated External Defibrillators | 91 | Alert Update: Adds an additional 91 units to Alert #2005010242 of 01/18/2005. Suspect electronic component may not function properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence. |
| 02/22/06 |
2006020292 URGENT |
Medtronic Emergency Response Systems, Inc., | Lifepak 500 AED | 4,080 | Component leads may have intermittent connection to the printed circuit board assembly (PCBA) pads which could render device inoperative. |
| 01/26/06 |
2006010481 | HeartSine Technologies,Ltd. | Samaritan AED | 11 | Unauthorized rework of the main circuit board performed by the board supplier in 28 instances. 11 defibrillators with reworked boards sold. |
| 07/20/05 | 2005070424 | Medtronic Emergency Response Systems, Inc. | LIFEPAK 20 | 3,924 | Alert Update: Adds one additional part number to RASMAS Alert #2005060180 of 06/24/05. The device defibrillator may not operate if the device is turned on during an AC Loss Alert. |
| 05/25/05 | 2005050316 | Philips Medical Systems | HeartStart MRx | 5,125 | May disarm and not deliver shock in Synchronized Cardioversion. |
| 05/09/05 | 2005050052 URGENT |
Welch Allyn | AED 20 | 597 | Potential terminal failure of the device to analyze patient's ECG. |
| 04/25/05 | 2005040270 URGENT |
Medtronic, Inc. | LIFEPAK 500 | 396 | Alert Update: Adds an additional 396 units to RASMAS Alert #2005020361 of 02/28/2005 and Alert #2005030080 of 03/02/05. AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. |
| 03/21/05 | 2005030259 URGENT |
HeartSine Technologies, Inc. | HeartSine Samaritan AED | 672 | The devices may shut down before delivering a shock. |
| 03/16/05 | 2005030227 URGENT |
Medtronic Emergency Response Systems, Inc | LIFEPAK 500 | 1,953 | Cannot detect patients at low end of the patient impedance range. |
| 02/28/05 | 2005020361 URGENT |
Medtronic, Inc. | LIFEPAK 500 | 1,924 | AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. |
| 01/18/05 | 2005010242 | Cardiac Science, Inc. | Powerheart AED G3 | 2,823 | May contain an electronic component that does not meet its full operating specifications. |
| 01/12/05 | 2005010212 | Philips Medical Systems | HeartStart MRx | 2,520 | Software versions below A.02.00 exhibit a delay in delivery with AED mode. |
| 11/10/04 | 2004110147 | Access CardioSystems | Access AED and ALS AED | ~10,000 | Shock delivery circuit may fail. |
| 08/13/04 | 2004080157 | Zoll Medical Corporation | M Series | 5,649 | Software defect may cause device to skip "Press Shock" prompt. |
| 06/29/04 | 2004060502 | Cardiac Science, Inc. | Powerheart AED | 6,167 | Faulty capacitors in AEDs result in self-test failures. |
| 06/09/04 | 2004060122 URGENT |
Cardiac Science, Inc. | Powerheart and FirstSave | 4,730 | Some AED batteries contain an incorrect fuse. |
| 05/24/04 | 2004050294 | Medtronic Physio Control Corp. | LIFEPAK 12 | 2,885 | Alert Update: Specifies Model/Product Number
and Stock Identifiers for Alert #2004110147 of 04/21/2004. Potential for display to go blank due to an electrical component that may fail. |
| 05/20/04 | 2004050177 | MRL, Inc., A Welch Allyn Company | AED 10 | 460 | Faulty components could result in shock button failure. |
| 05/05/04 | 2004050034 | Medtronic Physio Control Corp. | LIFEPAK 500 | 7,028 | Potential battery cell rupture. |
| 01/29/04 | 2004010322 | Access CardioSystems | Access AED and Access ALS | 143 | Failure to operate due to faulty component on the circuit board. |
| 09/29/03 | 2003090132 | Philips Medical Systems | HeartStart XL | 16,736 | Additional instructions for configuration for selecting Power on Lead. |