RecallRadar

FDA Device recall Z-1084-2019

Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120

On 2019-04-10 the FDA classified a Class II recall of Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120 by Advanced Bionics, citing the sound processors were loaded with the incorrect firmware.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1084-2019
ClassificationClass II
Statusterminated
Initiated2019-02-06
Published2019-04-10
Last updated2026-09-13 11:55 UTC
CompanyAdvanced Bionics
DistributionNC

Product

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.

Reason

The sound processors were loaded with the incorrect firmware.

Identifiers

code_info
Model Cl-5245-120 - Serial number 1042838, UDI (01)07630016837814(11)150729(21)1042838; Model Cl-5245-140 - Serial n…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1084-2019%22

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