Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,

FDA device recall Z-1155-2014 · posted 2014-03-07 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

Reason for recall

MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing

Action taken

Philips Healthcare issued and Urgent Medical Device Correction notification/Field Safety Notice on 02/18/14 to inform customers of the issue, 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 hardware upgrade, provided that if you observe that the MRx is displaying a Red X in the Ready For Use (RFU) indicator\during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this is observed you should turn the Therapy Knob to Monitor. An INOP message describing the failure is displayed. If needed, run an Operational Check for further information. If the condition persists, take the device out of use and call for service. Identify a readily available backup defibrillator to use in the event the affected HeartStart MRx fails to deliver therapy. Philips will perform a hardware upgrade (replace therapy boards) free of charge to be installed by a Philips Field Service Engineer. Contact your local Philips representative or call us at 1-800-722-9377.

Root cause

Component design/selection

Status

Terminated

Product code

MKJ

Quantity affected

3541 units

Distribution

Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEB

Date initiated

2014-02-18

Date posted

2014-03-07

Date terminated

2020-09-11

Location

Andover, MA