Advanced Bionics, LLC: Medical Device Recall in 2019 - (Recall #: Z-1083-2019)

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 CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

Product Classification:

Class II

Date Initiated: February 6, 2019

Date Posted: April 10, 2019

Recall Number: Z-1083-2019

Event ID: 82241

Reason for Recall:

The sound processors were loaded with the incorrect firmware.

Status: Terminated

Product Quantity: 4 sound processors

Code Information:

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.

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