Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The product is used by qualified medic
FDA device recall Z-2294-2011 · posted 2011-05-25 · Terminated
Recall details
- Recalling firm
- ZOLL Medical Corporation
- Reason for recall
- Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy
- Action taken
- The firm, Zoll, sent an "Urgent Medical Device Correction" letter dated April 22, 2011 via UPS to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately alert all E Series BLS users to this problem; instruct users to not touch patient and keep the patient still during ECG analysis, Instruct users that if they experience this problem, to press the Analyze button again, and contact ZOLL Technical Service for the software upgrade kit. The letter also states that affected units can remain in service until the software has been updated. If you have any questions, please contact 24/7 technical support at 1 (800) 348-9011 or +1 (978) 421-9460.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 874 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Finland, Germany, Malaysia and United Kingdom.
- Date initiated
- 2011-04-21
- Date posted
- 2011-05-25
- Date terminated
- 2014-01-23
- 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 |