FDA Medical Device Recalls (openFDA)
Philips North America, LLC: Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.
- Recall number
- Z-2794-2020
- Recalling firm
- Philips North America, LLC
- Product
- Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.
- Status
- Terminated
- Initiated
- 2020-07-16
- Posted
- not on file
- Terminated
- 2021-08-03
- Reason
- The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
- Root cause
- Process control
- Action
- On July 16, 2020, the firm distributed an Urgent Medical Device Correction letter to all affected customers. Customers were informed of the product issue and were instructed to do the following: - The MRx is safe to use and can remain in service if the device does not exhibit any of the behaviors described in this Notice (the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user.) - If an MRx device experiences a switch failure as described, contact your local Philips representative, who can arrange for a replacement of the switch at no charge. - Continue to perform the Shift and Operational Checks described in the Instructions for Use, Maintenance Chapter - To detect possible switch failures as early as possible, conduct Weekly Shock Tests (part of the Shift Check in the IFU) on a daily basis - It is not necessary to perform a Shock Test on days when an Operational Check is performed, since an Operational Check includes a Shock Test. - Keep a copy of the customer letter with each HeartStart MRx Instructions for Use. - To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to the firm. If the MRx Therapy Switch fails, Philips will arrange for the replacement of the switch at no charge to the customer.
- Quantity
- 95,212 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- All devices are affected
- 510(k) numbers
- ["K031187"]
- 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