Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6

FDA device recall Z-0613-2014 · posted 2013-12-31 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

Reason for recall

Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and

Action taken

Philips issued a Medical Device Correction letter April 2013 to all affected customers along with an IFU Addendum titled, HeartStart MRx Electromagnetic Compatibility. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the condition could be avoided by operating the device on external AC or external DC power. Customers were instructed to follow the device instructions when using battery power to minimize or eliminate potential interference from other RF sources. Customers with questions were instructed to contact their local Philips representative. For questions regarding this recall call 978-687-1501.

Root cause

Environmental control

Status

Terminated

Product code

MKJ

Quantity affected

64,972

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to the following countries: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND

Date initiated

2013-04-10

Date posted

2013-12-31

Date terminated

2017-04-13

Location

Andover, MA

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