—#180972

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K063375
Affected lot / code info: Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J

Why it was recalled

Damaged ESD bags used for storing components in Processor PCA Replacement Kits

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.

Timeline

Recall initiated: 2020-04-10
Terminated: 2021-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.