Philips QCPR Meter Recall for CPR Feedback and Injury Information
Philips is recalling QCPR meters used with HeartStart defibrillators to inform users of correct pad placement and CPR-related injuries.
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 classified as FDA Class II and involves providing safety information regarding CPR performance and device usage, which aligns with the rubric for moderate severity involving minor labeling or usage errors without reported serious injury.
Plain-English summary
Philips Electronics North America Corporation is recalling the Philips QCPR Meter, which is used with Philips HeartStart FR3 and MRx automated external defibrillators. The recall involves 28,094 units distributed worldwide and across the United States. The specific models affected are 861444, 861332, 989803139951, 989803162401, and 989803149941.
The purpose of this recall is to inform users of the correct placement of the disposable adhesive pad on the QCPR meter and to provide information regarding injuries associated with the proper performance of CPR. This action is being taken as required by the Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered on October 31, 2017, between the United States of America and Philips North America.
Users of these devices should refer to the recall notice for specific instructions on pad placement and safety information regarding CPR performance. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Philips QCPR Meter - used with FR3 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
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- 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.
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