Z-1084-2019Class II

Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black...

Name: Z-1084-2019 Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black...
Creator: Advanced Bionics, LLC
Published: 2019-02-06
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2019-02-06 / Terminated / root cause: manufacturing process

FDA source

Advanced Bionics, LLC began a recall of Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150 on 2019-02-06. FDA classified it as Class II and gives the reason as "The sound processors were loaded with the incorrect firmware". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1084-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-06
Posted: 2019-04-03
Terminated: 2024-02-01
Recalling firm: Advanced Bionics LLC
Product: Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Product code: MCM Implant, Cochlear
Reason for recall: The sound processors were loaded with the incorrect firmware.
Root cause tag: manufacturing process
FDA 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 in commerce: 3 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1084-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1083-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-03
Z-1084-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-03
Z-1085-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-03

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)