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AED Manufacturer's Bulletins
- Medical Device Recall: LifePak CR Plus Automated External Defibrillators: The product was recalled because the AED
instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service, or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.
Link to the Website September 11, 2008
- Defibtech LLC said problems with the software in its Lifeline AEDand ReviveR AED models may fail to flag a previously detected low battery during some tests. If that occurs and the battery is indeed drained, the device may not be able to deliver the defibrillation shock needed to restart a person's heart. Link to website and corrective action 03/2007.
- MEDTRONIC UNIT HALTS DEFIBRILLATOR SALES
Source: Staff and wire reports Fridley-based Medtronic's Physio-Control unit indefinitely suspended shipments of external defibrillators and other emergency-response gear because of quality-control problems at a factory in Redmond, Wash. The suspension will address weaknesses in "the overall quality system" in the Redmond factory that were identified by the U.S. Food and Drug Administration and the company, Medtronic spokesman Rob Clark said. The quality issues are related to manufacturing...
Published on January 17, 2007, Page C2, St.Paul Pioneer Press (MN)
- MRL, Inc. AED Recall June, 2006 (PDF)
- Boston Scientific AED Recall June, 2006 word doc.
