FDA recall Z-1923-2019

Philips North America, LLC · Class II · device

Product

Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

Reason for recall

The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.

Distribution

Nationwide domestic distribution. Worldwide distribution.

Key facts

Status: Terminated
Initiation date: 2019-06-07
Report date: 2019-07-17
Termination date: 2020-05-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1923-2019