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 Initiated
- March 24, 2010
- Posted
- May 7, 2010
- Terminated
- January 23, 2014
- Recall Number
- Z-1547-2010
- Quantity
- 1383 units
- Firm Location
- Chelmsford, MA
Reason for Recall
Device issued Shock Advised message but failed to auto-charge the defibrillator.
Distribution
Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.
Lot / Code Info
Software versions 4.XX, 6.XX and 7.0X in the E Series BLS Model.
Root Cause
Software design
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.