Class 1 Medical Device Recalls - Welch Allyn PIC 50™ Automated External Defibrillators

Date Recall
Initiated:

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
1000 Asbury Drive
Suite 17
Buffalo Grove, IL 60089-4551

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:

• MRL, Inc sent Urgent Medical Device Recall letters dated 7/05/06 to its customers who purchased PIC 50™ AEDs, which contained a list of the affected units' parts/serial numbers and requested that customers inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing.
• The recall letters instructed customers to respond by fax or mail to the notification within 5 working days if the unit has displayed the “Defib Comm” error, and within 30 days if it has not displayed the “Defib Comm” error.
• Within 10 days of receiving a response to the recall notice, MRL, Inc. will provide PIC 50 owners with a loaner PIC 50 while their unit is being serviced, with instructions on how to return their unit for correction.