Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The H
FDA device recall Z-1896-2012 · posted 2012-06-27 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- HeartStart MRx Unexpected Pads/Paddles ECG Failure
- Action taken
- Philips issued an Urgent Voluntary Medical Device Correction/Field Safety Notice letter on June 20, 2012. The letter informs customers of the issue, identifies details (including models and software versions applicable) of units affected, gives instructions on actions to be taken until the correction is available, and identifies what action Philips plans to eliminate or remedy the issue. The letter states that a Philips Healthcare representative will contact customers to arrange for the replacement of the Power PCA in all the affected devices. Philips will complete the installation free of charge. For questions or support concerning this issue contact your local Philips representative at 1-800-722-9377.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 2914 units
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, EL SALVADOR, ETHIOPIA, FRANCE, GERMANY, HONG KONG, INDIA, INDONESI
- Date initiated
- 2012-06-20
- Date posted
- 2012-06-27
- Date terminated
- 2017-03-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |