HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx is for use for the te

FDA device recall Z-0322-2011 · posted 2010-11-08 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on: " Default ECG Lead Behavior " Synchronized Cardioversion using External Paddles

Action taken

Philips issued an Urgent Voluntary Medical Device Correction notification/Field Safety Notice and an Instructions for Use Addendum on July 20, 2010, to affected customers. The Notice identified the product, the problem, and the action customers should take. In the USA, the notification sent to all affected customers via UPS and confirmation of delivery would be tracked. Outside the USA, Philips representatives in the affected geographies would manage their mailings locally. Customers were instructed to review the HeartStart MRx Instructions for Use addendum and keep a copy with their equipment - Instructions for Use. Additionally, they were instructed to insure that all users are fully trained on the MRx and, in particular, ensure that they review and understand have reviewed and understand the additional detail provided in the notification. For questions regarding this recall call (800) 722-9377.

Root cause

Labeling design

Status

Terminated

Product code

MKJ

Quantity affected

41,119 units

Distribution

Worldwide Distribution - US Nationwide and the countries of: CANADA AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULGARI

Date initiated

2010-07-16

Date posted

2010-11-08

Date terminated

2012-09-05

Location

Andover, MA

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