Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart
FDA device recall Z-0683-2018 · posted 2018-02-22 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- 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
- Action taken
- Philips sent an Medical Device Recall letter dated January 19, 2018 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately return the attached reply card. For question contact your local Philips representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LIX
- Quantity affected
- 28094 in total
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2018-01-29
- Date posted
- 2018-02-22
- Date terminated
- 2020-05-05
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K130684) | Philips Medical Systems | 2013-10-18 |