Recall Z-1714-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
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.
| Date | Sep 17, 2008 (initiated Jan 23, 2008) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010214 | FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 Survivalink Corp., Feb 22, 2001 |