FDA recall Z-1499-2020

Philips North America, LLC · Class II · device

Product

HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.

Reason for recall

Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.

Distribution

US Nationwide domestic distribution. Worldwide foreign distribution.

Key facts

Status
Terminated
Initiation date
2020-02-26
Report date
2020-03-25
Termination date
2022-12-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1499-2020