Date Initiated by Firm |
April 10, 2020 |
Create Date |
May 20, 2020 |
Recall Status1 |
Terminated 3 on February 10, 2021 |
Recall Number |
Z-2064-2020 |
Recall Event ID |
85462 |
510(K)Number |
K063375
|
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
|
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. |
Code Information |
Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
Philips Customer Services 978-659-3000
|
Manufacturer Reason for Recall |
Damaged ESD bags used for storing components in
Processor PCA Replacement Kits
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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