Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personn
FDA device recall Z-1714-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Cardiac Science Corporation
- Reason for recall
- Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 63
- Distribution
- Distributed Nationwide US and Canada and Internationally to: Norway and Guam
- Date initiated
- 2008-01-23
- Date posted
- 2008-09-17
- Date terminated
- 2011-12-08
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 (K010214) | Survivalink Corp. | 2001-02-22 |