FDA-Device2019-07-17Class II
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Philips North America, LLC
Hazard
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.
Sold states
Nationwide domestic distribution. Worldwide distribution.
Affected count
97,794 Units
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1923-2019Don't want to check this manually?
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