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.
Reported: May 27, 2020 Initiated: April 10, 2020 #Z-2064-2020
Product Description
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.
Reason for Recall
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 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.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips North America, LLC. Units affected: 8 units (2 US and 6 OUS).
Why was this product recalled? ▼
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2064-2020.
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