Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M

FDA device recall Z-1797-2013 · posted 2013-07-24 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation.

Action taken

Philips sent an Urgent Medical Device Correction letter on June 19, 2013, to all affected customers. The letter informed customers of the issue, identified details of the units affected, gave instructions on actions to be taken by the customer and identified what action Philips planned to take to remedy the issue. Philips will perform a software upgrade and replace the label on the unit that outlines the steps for Synchronized Cardioversion with a revised label for all affected units at no charge to the customer. 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: You can continue to use your MRx prior to receiving the software upgrade and device label revision, provided that you follow the instruction provided. Customers with questions were instructed to contact their local Philips representataive or call 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Root cause

Software design

Status

Terminated

Product code

MKJ

Quantity affected

66,150 units

Distribution

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

Date initiated

2013-06-19

Date posted

2013-07-24

Date terminated

2016-12-16

Location

Andover, MA

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