FDA Medical Device Recalls (openFDA)
ZOLL Medical Corporation, World Wide Headquarters: ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
- Recall number
- Z-1547-2010
- Recalling firm
- ZOLL Medical Corporation, World Wide Headquarters
- Product
- ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
- Status
- Terminated
- Initiated
- 2010-03-24
- Posted
- 2010-05-07
- Terminated
- 2014-01-23
- Reason
- Device issued Shock Advised message but failed to auto-charge the defibrillator.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 1383 units
- Distribution
- Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.
- Lot, serial or model codes
- Software versions 4.XX, 6.XX and 7.0X in the E Series BLS Model.
- 510(k) numbers
- K042007
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1220908
- Firm city
- Chelmsford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28