GMRL, Inc., and FDA notify healthcare professionals of a Class I
recall of Welch Allyn PIC 50 Automated External Defibrillators
Welch Allyn
Defibrillator News Alerts and Lawyer Updates
Recall Notice from the U.S. Food & Drug
Administration
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.
Class I recalls are the most serious type of recall and involve
situations in which there is a reasonable probability that use of
the product will cause serious injury or death.
Welch Allyn PIC 50 DEFIBRILLATOR RECALL LAWYERS / ATTORNEYS
If you or a loved one has suffered injuries because of the Welch
Allyn PIC 50 defribillator,, you should consider receiving a free legal evaluation from an experienced
Welch Allyn PIC 50 lawyer. For a free evaluation of your situation please complete the following form and a
Welch Allyn PIC 50 attorney will contact you promptly -- free of
charge.
Welch Allyn PIC 50 DEFIBRILLATOR NEWS
& LAWYER UPDATES
Recall Notice from the U.S. Food & Drug Administration
June 30, 2006
Defibrillator Maker Recalls More than 350 Devices Sold in U.S.
MedPage Today - June 30, 2006
MRL Issues Worldwide Recall of Selected AED20 Automatic External
Defibrillators
Kansas City InfoZine News - June 30, 2006
Contact us for
Welch Allyn PIC 50
Defibrillator Lawyer Representation in Los Angeles, CA; Baltimore, MD;
Boston, MA, St. Paul, MN; St. Louis, MO; New York, NY; Raleigh, Greensboro, Charlotte, NC; Scranton Wilkes-Barre Harrisburg
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