Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll M
FDA device recall Z-1167-2008 · posted 2008-06-28 · Terminated
Recall details
- Recalling firm
- ZOLL Medical Corporation, World Wide Headquarters
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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, Singa
- Date initiated
- 2008-01-15
- Date posted
- 2008-06-28
- Date terminated
- 2017-02-06
- Location
- Chelmsford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL E SERIES DEFIBRILLATOR (K042007) | Zoll Medical Corp | 2005-04-07 |