FDA Medical Device Recalls (openFDA)
Philips North America, LLC: HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
- Recall number
- Z-1499-2020
- Recalling firm
- Philips North America, LLC
- Product
- HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
- Status
- Terminated
- Initiated
- 2020-02-26
- Posted
- not on file
- Terminated
- 2022-12-08
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 97788 units
- Distribution
- US Nationwide domestic distribution. Worldwide foreign distribution.
- Lot, serial or model codes
- All units are affected by this recall
- 510(k) numbers
- ["K063375"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28