HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
This recall has been terminated (originally issued February 26, 2020).
- Company
- Philips North America, Llc
- Recall Initiated
- February 26, 2020
- Terminated
- December 8, 2022
- Recall Number
- Z-1499-2020
- Quantity
- 97788 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All units are affected by this recall
Root Cause
Device Design
Action Taken
On February 26, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that if the device is dropped or subjected to a severe mechanical shock, it may suffer internal damage even in the absence of visible external damage or the Ready for Use indicator unit does not immediately indicate a problem. Customers were instructed to inform all users that if the device is dropped or subjected to severe mechanical shock and the exterior case is still intact, they should immediately perform an operational check as described in the IFU section "Performing the Operational Check" in the Maintenance Chapter. The unit should be taken out of service and Philips Customer Service contacted if the unit is visibly damaged or if the device fails the operational check, i.e., if the RFU indicator changes to a red-X or the device emits a periodic audible chirp, as described in the IFU. Customers were instructed to insert a copy of the customer notice into each copy of the HeartStart MRx IFU. If you need further information or support concerning this notification, please contact your local Philips representative or call the firm at 1-800-722-9377.