FDA Medical Device Recalls (openFDA)
Cardiac Science Corporation: 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.
- Recall number
- Z-1714-2008
- Recalling firm
- Cardiac Science Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-01-23
- Posted
- 2008-09-17
- Terminated
- 2011-12-08
- Reason
- Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
- Root cause
- Labeling design
- Action
- 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.
- Quantity
- 63
- Distribution
- Distributed Nationwide US and Canada and Internationally to: Norway and Guam
- Lot, serial or model codes
- Lot numbers: 123004, 92804, 62305, 63005, 52504, 50405, 33105, 12605, 12505, 7715, 6952, and 6838
- 510(k) numbers
- ["K010214"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 2112020
- Firm city
- Bothell
- Firm state
- WA
- 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