Date Recall |
June 30, 2006 |
Product: |
Welch Allyn PIC 50™ Automated External Defibrillators, catalog #97108X manufactured from March 2002 through October 2004. |
Use: |
This device is an automated external defibrillator (AED) that is intended for use by emergency or medical personnel to monitor and treat patients with symptoms of cardiac dysfunction. The device monitors patient vital signs and delivers an electrical shock (defibrillation) to the heart if needed to restore normal heart rhythm. |
Recalling Firm: |
MRL, Inc., A Welch Allyn Company |
Reason for Recall: |
An electrical contact problem may result in the device’s failure to provide a defibrillation shock, which could result in delay or failure to resuscitate the patient. This failure may be accompanied by various error messages on the display panel, including the “Defib Comm” error message. |
Public Contact: |
Consumers with questions may contact the company at (800) 462-0777 or (847) 520-0300 for more information. |
FDA District: |
Chicago |
FDA Comments: |
|
For additional information on this product recall, see the company’s press release. |
Updated July 10, 2006
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