Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes.
This recall has been terminated (originally issued September 17, 2008).
- Company
- Cardiac Science Corporation
- Recall Initiated
- January 23, 2008
- Posted
- September 17, 2008
- Terminated
- December 8, 2011
- Recall Number
- Z-1714-2008
- Quantity
- 63
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
Distribution
Distributed Nationwide US and Canada and Internationally to: Norway and Guam
Lot / Code Info
Lot numbers: 123004, 92804, 62305, 63005, 52504, 50405, 33105, 12605, 12505, 7715, 6952, and 6838
Root Cause
Labeling design
Action Taken
On 1/23/08 the firm issued a letter titled "9055 Electrode Adaptor IFU Update" to consignees sent via certified return receipt requested. Enclosed with the letter is an updated Instructions For Use, part number 70-00180-01, revision C. Consignees were advised to discard their old Instructions For Use. For assistance, contact Cardiac Science at 1-888-466-8686.