Date Recall Initiated |
August 28, 2008 |
---|---|
Product: |
LifePak CR Plus Automated External Defibrillator This device was manufactured from May 20, 2004 through August 11, 2007 and distributed from May 20, 2004 through December 4, 2007. Two hundred forty-nine (249) devices are affected. |
Use: |
These devices are used by emergency or medical personnel, or by others who have taken the appropriate training to use this AED. The devices are intended to treat adults in cardiopulmonary arrest (heart attack). They analyze an unconscious patient’s heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm. |
Recalling Firm: |
Physio Control, Inc. 11811 Willows Rd NE Redmond, Washington 98052-2003 |
Reason for Recall: |
The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock). |
Public Contact: |
Customers with questions may visit the following website at www.physio-control-notices.com/config for more information or to enter the serial numbers of their devices to determine if they are affected by this action. Customers may also call Physio-Control Technical Support at 1-800-442-1142, option 5, between 6:00 a.m. and 4:00 p.m. (Pacific Time). |
FDA District: |
Seattle |
FDA Comment: |
Physio Control began calling their customers on August 28, 2008 and:
The company completed notifying its customers on September 2, 2008 Healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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Updated September 16, 2008
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