Recall Z-0683-2018 ยท LIX Aid, Cardiopulmonary Resuscitation
Philips Electronics North America Corporation
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 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC gu
| Date | Feb 22, 2018 (initiated Jan 29, 2018) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 28094 in total |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130684 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems, Oct 18, 2013 |