FDA recall Z-1083-2019

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2019-02-06

Report date

2019-04-10

Termination date

2024-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1083-2019