Z-1499-2020 Class II Terminated
FDA device recall Z-1499-2020 was initiated by Philips North America, LLC on February 26, 2020 and is designated Class II. 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 se… The recall status is terminated (terminated December 8, 2022). Affected quantity: 97788 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 26, 2020
- Termination Date
- December 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97788 units
Product Description
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
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 Pattern
US Nationwide domestic distribution. Worldwide foreign distribution.
Code Information
All units are affected by this recall