—#160142

Product

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

FDA product code: MSX — System, Network And Communication, Physiological Monitors
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K031187, K040404, K051134, K061707, K062233, K063375
Affected lot / code info: 20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483

Why it was recalled

Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The Philips 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. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 20 units affected. 18 domestic, 2 foreign.

Timeline

Recall initiated: 2017-09-28
Terminated: 2018-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160142. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.