Company: Philips Medical Systems, Inc.
Date of Enforcement Report 11/11/2015
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Recall Number Z-0204-2016
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication.
Philips Medical Systems, Inc., Andover, MA on 11/19/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE