Philips North America, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J
Products Sold
Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J
Philips North America, LLC is recalling HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartSt due to Damaged ESD bags used for storing components in Processor PCA Replacement Kits. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026