Philips North America, LLC recalls Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M…

Recall date

June 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1923-2019

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Nationwide domestic distribution. Worldwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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