Z-2064-2020Class II

HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx...

Name: Z-2064-2020 HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx...
Creator: Philips North America, LLC
Published: 2020-04-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-04-10 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended... on 2020-04-10. FDA classified it as Class II and gives the reason as "Damaged ESD bags used for storing components in Processor PCA Replacement Kits". 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-2064-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-10
Posted: 2020-05-20
Terminated: 2021-02-10
Recalling firm: Philips North America LLC
Product: HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital 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: Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips Healthcare ssued Medical Device Correction letter dated April 10, 2020 via USP stating reason for correction, health risk and action to take: If the Processor Board PCA Replacement Kit has not yet been installed in a Heart5tart MRx Monitor/Defibrillator, quarantine the kit until Philips can replace it. If the PCA has been installed in a HeartStart MRx Monitor/Defibrillator, continue to monitor the status of the device as recommended in the Instructions for Use, including performing Operational Checks routinely as recommended in the Instructions for Use. Verify your MRx does not show a red X nor is it emitting a periodic audio chirp as this could be an indicator a failure has been detected. When the device is turned on, the device will display INOP messages for any failures detected. If a failure has been detected, take the device out of use and contact your local Philips representative. If an affected Processor Board PCA Replacement Kit 453563478461 is identified, please contact your local Phillips representative. Once the customer has contacted their local Philips representative with their HeartStart MRx Monitor/Defibrillator serial number and also confirmed the affected Processor Board PCA serial number, Philips will provide a replacement Processor Board PCA 453563478461 Replacement Kit free of charge. Further information or support concerning this issue, contact your local Philips representative or call us at 1-800-722-9377.
Quantity in commerce: 8 units (2 US and 6 OUS)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.
Product codes and lots: Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2064-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2064-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20

Product code MKJ

K063375Class IIIHeartstart Mrx, Models M3535a or M3536aPhilips Medical Systems / cleared 2007-01-11

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)