Z-2053-2020Class II

Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) -

Name: Z-2053-2020 Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) -
Creator: Philips North America, LLC
Published: 2020-04-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-04-13 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the... on 2020-04-13. FDA classified it as Class II and gives the reason as "The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with...". 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-2053-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-13
Posted: 2020-05-20
Terminated: 2021-04-07
Recalling firm: Philips North America LLC
Product: Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital 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. It must be used by or on the order of a physician.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 13, 2020, the firm distributed URGENT Medical Device Recall letters to affected customers. Customers were informed of the device defect, which may result in the following unexpected behavior: - The device may not turn on. - The device may not perform the selected function. - The device may deliver a shock with an energy level different from the setting selected by the user. There have been three reported patient deaths potentially associated with the failure of the HeartStart XL Monitor/Defibrillator rotary therapy selector switch. Customers were advised that the HeartStart XL Defibrillator/Monitor has been discontinued and has reached its end of life. Therefore, custoemrs should replace and retire their units as soon as practically possible. Customers should continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure until your units are safely retired. If you identify a device that exhibits any of the behaviors described above, or which fails shift or operational checks, immediately remove it from service. Customers were asked to complete and fax or email the included customer reply form to Philips. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377.
Quantity in commerce: 94,034 units
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: All units. Product has been discontinued.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2053-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2053-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20

Product code MKJ

K001725Class IIIHeartstream Xl Defibrillator/monitor, Model M4735aAgilent Technologies, Inc. / cleared 2000-09-08

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)