FDAClass IIFebruary 28, 2018

Philips QCPR Meter - used with MRx Product Usage: The recall

Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external…

Why was Philips QCPR Meter - used with MRx Product Usage: The recalled?

Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America

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?

All QCPR meters and sensors in use with HeartStart MRx and FR3. MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941

Product
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external…
Recalling firm
Philips Electronics North America Corporation
Quantity
28094 in total
Distribution
Worldwide Distribution - US Nationwide
Recall date
February 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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