The Recall Desk
ModerateFDA (Devices)·Z-1085-2019·Announced 2019-04-10

Advanced Bionics Recalls Naída CI Q90 Sound Processor Due to Firmware Error

Advanced Bionics is recalling one Naída CI Q90 Sound Processor because it was loaded with incorrect firmware. The device was distributed in North Carolina and several foreign countries.

What this means for you

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 source text identifies a firmware error but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Advanced Bionics, LLC is recalling one Naída CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. The recall is due to the device being loaded with incorrect firmware.

The affected unit has serial number 1066444 and UDI (01)07630016838118(11)180725(21)1066444. Distribution was made to North Carolina, as well as to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government or military distribution.

Consumers with this specific device should contact Advanced Bionics for instructions on how to proceed with the recall.

The recalled product

Product
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Affected units
1

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 (2)

  • Serial number 1066444
  • UDI (01)07630016838118(11)180725(21)1066444.

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.

See all 3 products in this recall →