Advanced Bionics, LLC: 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.

Is my product affected?

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.

• UPC 07630016838057
• UPC 07630016829710
• UPC 07630016838071

Check against the official notice below — it lists the full affected range.

What happened

Advanced Bionics, LLC is recalling four Naída CL Q30 Sound Processors in three color variants (Sand Beige, Silver Gray, and Velvet Black) because they were loaded with incorrect firmware. The affected units have specific serial numbers: one Sand Beige model (1047584), two Silver Gray models (1047481 and 1047482), and one Velvet Black model (1082276).

The sound processors were distributed to North Carolina and to several countries including Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. The recall record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The sound processors were loaded with the incorrect firmware.

Details from the source

Reason for recall: The sound processors were loaded with the incorrect firmware. 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. Quantity: 4 sound processors Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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