Recall Z-1913-2018 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Electronics North America Corp.
Philips HeartStart FRx AED.
| Date | Mar 14, 2018 |
| Status | Terminated |
| Reason | An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed. |
| Root cause | Nonconforming Material/Component |
| Action | Letters dated 2/16/2018 for U.S. customers were issued via certified mail on 3/14/2018. Letters to customers outside of the U.S. were localized in conjunction with the local Philips market organizations and are in progress. |
| Quantity | Total for FRx and HS1 - 660,519 defibrillators |
| Distribution | Distribution was nationwide and to Puerto Rico. There was also government/military distribution. Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Brunei Darussala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050004 | PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 Philips Medical Systems, Feb 25, 2005 |