Advanced Bionics, LLC: Medical Device Recall in 2019 - (Recall #: Z-1084-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 6, 2019

Date Posted: April 10, 2019

Recall Number: Z-1084-2019

Event ID: 82241

Reason for Recall:

The sound processors were loaded with the incorrect firmware.

Status: Terminated

Product Quantity: 3 sound processors

Code Information:

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 Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated