Z-0489-2018Class I

MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969

Name: Z-0489-2018 MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969
Creator: Philips North America, LLC
Published: 2017-07-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-07-12 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular... on 2017-07-12. FDA classified it as Class I and gives the reason as "Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode". 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-0489-2018
Classification: Class I
Status: Terminated
Initiated: 2017-07-12
Posted: 2018-02-08
Terminated: 2020-05-27
Recalling firm: Philips North America LLC
Product: MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: 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: Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Healthcare sent an Urgent Medical Device Correction Notification/Field Safety Notice letter dated June, 2017 to their customers. The letter identified the affected product, problem, hazard involved and actions to be taken. Philips is requesting that customers report if their device fails to function as intended. Philips will contact all customers for device replacement once parts are available. If you need further information or support concerning this action, please contact your local Philips representative.
Quantity in commerce: 71 units
Distribution: No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
Product codes and lots: Serial Numbers: US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241, US00602242, US00602243, US00602244, US00602245, US00602246, US00602247, US00602248, US00602250, US00602251, US00602252, US00602253, US00602254, US00602344, US00602345, US00602346, US00602347, US00602348, US00602349, US00602350, US00602351, US00602352, US00602353, US00602354, US00602355, US00602356, US00602357, US00602358, US00602359, US00602360, US00602361, US00602362, US00602363, US00602364, US00602365, US00602366, US00602367, US00602368, US00602369, US00602370, US00602371, US00602372, US00602373, US00602374, US00602375, US00602376, US00602377

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0489-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0489-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-08

Product code MKJ

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)