HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6

FDA device recall Z-0219-2016 · posted 2015-11-05 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

Reason for recall

MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed

Action taken

Philips Healthcare issued on 12/23/14 The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. 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. If the MRx reboots during clinical use, continue to treat the patient according to your organizations protocol, reinitiating therapy if necessary.

Root cause

Software design

Status

Terminated

Product code

MKJ

Quantity affected

75,693 units

Distribution

Worldwide Distribution - US Nationwide and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOWINA, BRAZI

Date initiated

2014-12-23

Date posted

2015-11-05

Date terminated

2020-09-09

Location

Andover, MA

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