Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the

FDA device recall Z-1118-2014 · posted 2014-02-26 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

Reason for recall

ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal

Action taken

Philips Healthcare issued Urgent Medical Device Correction notification/Field Safety Notice on 2/18/14 informs customers of the issue and identifies what action Philips plans to take to remedy the issue. Philips will perform a hardware upgrade free of charge. Philips is asking customers to follow theAction 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, while remaining aware that if the problem were to occur you could experience the following symptoms: Loss of demand mode pacing, nability to perform synchronized cardioversion with paddle andDisruption of ECG monitoring or INOP messages. Not every serial number within the listed range is affected by this Medical Device Correction. If you have questions about whether your MRx is affected by this issue, please contact Philips at 1-800-722-9377.

Root cause

Component design/selection

Status

Terminated

Product code

MKJ

Quantity affected

49929 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 BRUNEI DA

Date initiated

2014-02-18

Date posted

2014-02-26

Date terminated

2018-02-20

Location

Andover, MA

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