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.
FDA Recall Z-1714-2008 · Posted 2008-09-17
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Recalling FirmCardiac Science Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-01-23
Date Terminated2011-12-08
Product Quantity63
Reason for Recall
Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
Distributed Nationwide US and Canada and Internationally to: Norway and Guam
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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