Z-0593-2014Class II

Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor...

Name: Z-0593-2014 Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor...
Creator: Philips Medical Systems, Inc.
Published: 2013-06-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-06-07 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems, Inc. began a recall of Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the... on 2013-06-07. FDA classified it as Class II and gives the reason as "Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0593-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-12-27
Terminated: 2017-03-22
Recalling firm: Philips North America LLC
Product: Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac 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: Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Philips sent a Customer Information Letter dated June 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. During an EI of the firm, the firm had not reported the correction to FDA. The Customer Information letter informs the customers what the behavior is and under what circumstances. The correction consisted of a replacement label that was provided free of charge to all units affected by this issue. Philips Healthcare representatives have been contact customers with affected devices to arrange for installation of the replacement label. To correct this issue, Philips will replace the label free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the replacement label. This issue does not affect current product shipments. I f you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. Philips apologizes for any inconvenience caused by this problem.
Quantity in commerce: 93 units
Distribution: Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.
Product codes and lots: Serial numbers: US00558442 - US00558461 US00561519 US00558531 - US00558532 US00561578 US00558615 US00562454 US00558758 - US00558759 US00562504 - US00562527 US00560165 - US00560166 US00562640 - US00562641 US00560738 - US00560739 US00562832 US00560740 - US00560745 US00563125 US00560872 US00563231 - US00563243 US00560909 US00564032 US00561068 US00564177 US00561209 US00564409 US00561447 - US00561452 US00564793

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0593-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0593-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27

Product code MKJ

K051134Class IIIHeartstart Mrx with Q-CPR Option, Models M3535a or M3536aPhilips Medical Systems / cleared 2005-09-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)