ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corp
FDA device recall Z-1547-2010 · posted 2010-05-07 · Terminated
Recall details
- Recalling firm
- ZOLL Medical Corporation, World Wide Headquarters
- Reason for recall
- Device issued Shock Advised message but failed to auto-charge the defibrillator.
- Action taken
- Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 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
- 1383 units
- Distribution
- Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.
- Date initiated
- 2010-03-24
- Date posted
- 2010-05-07
- 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 |