Advanced Bionics, LLC: 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.

Is my product affected?

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.

• UPC 07630016837814
• UPC 07630016838262
• UPC 07630016838279

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

What happened

Advanced Bionics, LLC is recalling three Nàida CI Q70 sound processors because they were loaded with incorrect firmware. The affected units are a Sand Beige model (serial number 1042838), a Silver Gray model (serial number 1013129), and a Velvet Black model (serial number 1033132). These devices were distributed to North Carolina and to several countries including Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran.

The source document does not specify what actions affected consumers should take regarding this recall.

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: 3 sound processors Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

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

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All FDA (Device enforcement) recalls