Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the terminat
FDA device recall Z-1986-2012 · posted 2012-07-11 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
- Action taken
- Philips Healthcare issued an Urgent Voluntary Medical Device Correction letter on June 20, 2012, to all affected customers. The Notification informs customers of the issue, identifies details (including models and software versions applicable) of units affected, instructions on actions to take while awaiting the correction, and identifies what action Philips plans to eliminate or remedy the issue A Philips Healthcare representative will contact customers to arrange for the updated R.03.03 software installation in all the affected devices. For questions customers were advised to call 1-800-722-9377. For questions regarding this recall call 978-687-1501.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 35 units
- Distribution
- Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA
- Date initiated
- 2012-06-20
- Date posted
- 2012-07-11
- Date terminated
- 2013-08-14
- 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 |