Z-2794-2020Class II

Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2...

Name: Z-2794-2020 Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2...
Creator: Philips North America, LLC
Published: 2020-07-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-07-16 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7... on 2020-07-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2794-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-16
Posted: 2020-08-13
Terminated: 2021-08-03
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 95,212 units
Distribution: Worldwide distribution.
Product codes and lots: All devices are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2794-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2794-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13

Product code MKJ

K031187Class IIIHeartstart Mrx, Model M3535aPhilips Medical Systems / cleared 2003-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)