The Recall Desk
ModerateFDA (Devices)·Z-0684-2018·Announced 2018-02-28

Philips QCPR Meter Recall for CPR Instruction and Injury Information

Philips is recalling QCPR meters to inform users of correct pad placement and injuries associated with CPR performance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary measure to provide information on pad placement and CPR-related injuries, without reports of specific device-caused harm or fatalities.

Plain-English summary

Philips Electronics North America Corporation is recalling the Philips QCPR Meter, which is used with HeartStart FR3 and MRx automated external defibrillators. The recall involves 28,094 units distributed worldwide and nationwide in the US.

The recall is being conducted to inform users of the correct placement of the disposable adhesive pad on the QCPR meter and to inform users of injuries associated with the proper performance of CPR. This action is required by a Consent Decree of Permanent Injunction entered on October 31, 2017, between the United States of America and Philips North America.

Affected users should refer to the recall notice for specific instructions regarding the adhesive pad placement and CPR injury information. The recall covers QCPR meters and sensors in use with HeartStart MRx and FR3 devices, including models 861444, 861332, 989803139951, 989803162401, and 989803149941.

The recalled product

Product
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installe
Affected units
28,094

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 861332
  • 989803139951
  • 989803162401
  • 989803149941

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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