Recall Z-1167-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation, World Wide Headquarters
Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.
| Date | Jun 28, 2008 (initiated Jan 15, 2008) |
| Status | Terminated |
| Reason | Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct. |
| Root cause | Software design |
| Action | Consignees were notified by an Urgent Device Correction letter sent on 1/14/08. The letter instructed users to complete and return a response form. Upon receipt of the response form, the recalling firm will have sent a software update. The letter also provided instructions for users to follow in order to avoid the software error before the software update was received. For additional information, contact 1-800-348-9011. |
| Quantity | 5,018 units |
| Distribution | Worldwide Distribution including USA and countries of Canada, AE, Australia, Belgium, Chile, Germany, Spain, France, UK, Hungary, India, Italy, Jordan, Kuwait, Netherlands, Russia, Saudi Arabia, Singapore and ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042007 | ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corp, Apr 7, 2005 |