Advanced Bionics Recalls Three Naída CI Q70 Sound Processors
Advanced Bionics is recalling three Naída CI Q70 Sound Processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect firmware, which is a functional defect rather than a direct physical injury risk like fire or shock, and no injuries or illnesses are reported in the source text.
Plain-English summary
Advanced Bionics, LLC is recalling three Naída CI Q70 Sound Processors. The specific units affected are Model Cl-5245-120 (Sand Beige), Model Cl-5245-140 (Silver Gray), and Model Cl-5245-150 (Velvet Black). The recall was initiated because the sound processors were loaded with the incorrect firmware.
The affected devices were distributed to North Carolina. Foreign distribution included Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government or military distribution. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who possess these specific serial numbers should contact Advanced Bionics for instructions on how to resolve the firmware issue. The specific serial numbers are 1042838, 1013129, and 1033132.
The recalled product
- 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.
- Manufacturer
- Advanced Bionics, LLC
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model Cl-5245-120 - Serial number 1042838
- UDI (01)07630016837814(11)150729(21)1042838
- Model Cl-5245-140 - Serial number 1013129
- UDI (01)07630016838262(11)181030(21)1013129
- and Model Cl-5245-150 - Serial number 1033132
- UDI (01)07630016838279(11)170525(21)1033132.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Advanced Bionics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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