Recall Z-2315-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation, World Wide Headquarters
ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
| Date | Sep 29, 2009 (initiated Aug 31, 2009) |
| Status | Terminated |
| Reason | Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy. |
| Root cause | Nonconforming Material/Component |
| Action | Zoll notified domestic consignees on August 31, 2009 and international consignees on September 1, 2009 by an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily tests per the recommendations provided in the R Series Operator's Guide. In the event of a failure, customers are to remove the device from service and contact biomedical or clinical engineering department per their facility's protocol. Units that operate as expected can remain in service and back-up monitor should be available in the event of a failure. Zoll's technical support departmen |
| Quantity | 247 units |
| Distribution | Worldwide Distribution -- USA, UK, Austria, Australia,, Canada, Switzerland, Germany, France, French Guiana, Jordan, Macedonia, Netherlands, Panama, Poland, Romania, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060559 | ZOLL R SERIES DEFIBRILLATOR ZOLL Medical Corporation, Aug 17, 2006 |