FDA Medical Device Recalls (openFDA)
Advanced Bionics, LLC: Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
- Recall number
- Z-1083-2019
- Recalling firm
- Advanced Bionics, LLC
- Product
- Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
- Status
- Terminated
- Initiated
- 2019-02-06
- Posted
- not on file
- Terminated
- 2024-02-01
- Reason
- The sound processors were loaded with the incorrect firmware.
- Root cause
- Process control
- Action
- On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.
- Quantity
- 4 sound processors
- 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.
- Lot, serial or model codes
- Model Cl-5260-120 - Serial number 1047584, UDI (01)07630016838057(11)180309(21)1045784; Model Cl-5260-140 - Serial number 1047481, UDI (01)07630016829710(11)151208(21)1047481; and Serial number 1047482, UDI (01)07630016829710(11)151208(21)1047482; and Model Cl-5260-150 - Serial number 1082276, UDI (01)07630016838071(11)180925(21)1082276.
- 510(k) numbers
- not on file
- PMA numbers
- ["P960058"]
- Product code
- MCM
- Firm FEI
- 1000220815
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28