ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricu
FDA device recall Z-2315-2009 · posted 2009-09-29 · Terminated
Recall details
- Recalling firm
- ZOLL Medical Corporation, World Wide Headquarters
- Reason for recall
- Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy.
- Action taken
- 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 department should be contacted at 1-800-348-9011 or +1-978-421-9460 to schedule the return of affected devices with the defect for replacement of the suspect component.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 247 units
- Distribution
- Worldwide Distribution -- USA, UK, Austria, Australia,, Canada, Switzerland, Germany, France, French Guiana, Jordan, Macedonia, Netherlands, Panama, Poland, Romania, and Saudi Arabia.
- Date initiated
- 2009-08-31
- Date posted
- 2009-09-29
- Date terminated
- 2012-05-30
- Location
- Chelmsford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL R SERIES DEFIBRILLATOR (K060559) | ZOLL Medical Corporation | 2006-08-17 |