FDAFDA · Food and drugs·Recall number Z-1084-2019
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.
Published April 10, 2019 · Recall initiated: February 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The sound processors were loaded with the incorrect firmware.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Bionics, LLC
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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