Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M353

FDA device recall Z-2347-2012 · posted 2012-09-10 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables

Action taken

Philips notified customers on June 20, 2012, by an Urgent Medical Device Correction notification/Field Safety Notice and a revised Instructions for Use addendum for each HeartStart MRx unit. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of units affected and and identifies the action. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Carefully read the attached HeartStart MRx Instructions for Use Addendum. Immediately implement ongoing therapy connection inspection on all of your MRx devices to detect wear from higher than expected levels of stress. The HeartStart MRx Instructions for Use Addendum describes how a user can identify wear. If wear is detected, remove affected devices immediately from use and contact Philips to arrange for service. WARNING: The service life of your therapy cables/external paddles is up to three years. To maintain reliable performance and reduce the possibility of failure during patient use, replace them every three years from the time they were initially placed into service or if they fail the inspection criteria in the attached Instructions for Use Addendum The addendum provides the customer with complete user information regarding ongoing inspections of port. In addition, service support will be provided for Therapy Port and Cables requirement replacements. Further information or support concerning this issue,contact your local Philips representative at 1-800-722-9377. For questions regarding this recall calll 978-687-1501.

Root cause

Equipment maintenance

Status

Terminated

Product code

MKJ

Quantity affected

58,701 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of : AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNE

Date initiated

2012-06-20

Date posted

2012-09-10

Date terminated

2017-02-15

Location

Andover, MA

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