FDAClass IIMay 27, 2020

HeartStart MRx Processor Board PCA Replacement Kits recall

HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is…

Why was HeartStart MRx Processor Board PCA Replacement Kits recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J

Product
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is…
Recalling firm
Philips North America, LLC
Quantity
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.
Recall date
May 27, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls