Welch Allyn PIC 50 AED Class I Recall
Some Welch Allyn PIC 50 Automated External Defibrillators (AEDs), catalog #97108X manufactured from March 2002 through October 2004 are recalled by their manufacturer as a matter of urgency. 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.
According to the FDA MRL, Inc sent Urgent Medical Device Recall letters dated 7/05/06 to its customers who purchased PIC 50 AEDs, with a list of the affected units’ parts/serial numbers and requested that customers inspect their units for the affected serial numbers and return the identified units for servicing. MRL will provide PIC 50 owners with a loaner unit while their product is being serviced. This closely follows recalls of AED20 defibrillators.
July 7, 2006 Related topics: Product Recalls, Emergency