Recall Z-1084-2019— Advanced Bionics, LLC
Class II · Terminated
Class II FDA medical device recall by Advanced Bionics, LLC, initiated 2019-02-06, terminated 2024-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.. Reason: The sound processors were loaded with the incorrect firmware..
- Recalling firm
- Advanced Bionics, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-06
- Terminated
- 2024-02-01
- Firm location
- Valencia, CA, United States
Product description
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Reason for recall
The sound processors were loaded with the incorrect firmware.
Data sourced from openFDA. This site is unofficial and independent of the FDA.