FDAClass IIApril 10, 2019

Na¿da CI Q90 Sound Processor recall

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

Why was Na¿da CI Q90 Sound Processor recalled?

The sound processors were loaded with the incorrect firmware.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Recalling firm
Advanced Bionics, LLC
Quantity
1 sound processor
Distribution
Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
Recall date
April 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls