CLASS II Device recall · Reported 10 Apr 2019 · FDA Enforcement Report

Na¿da CL Q30 Sound Processor, Sand Beige recalled by Advanced Bionics

Advanced Bionics is recalling Na¿da CL Q30 Sound Processor, Sand Beige, distributed in North Carolina. The recall was initiated on 6 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled4 sound processors

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1083-2019
FDA event ID: 82241
Recalling firm: Advanced Bionics, Valencia, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Feb 2019
FDA classified: 3 Apr 2019
Reported: 10 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Feb 2019	Recall initiated by company
3 Apr 2019	Classified by FDA	+56 days
10 Apr 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The sound processors were loaded with the incorrect firmware.

Product as listed by the FDA

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.

Where it was distributed

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.

North Carolina

Questions about this recall

Why was it recalled?

The sound processors were loaded with the incorrect firmware.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82241

This product is part of a recall event; the main page for the event is Na¿da CI Q70 Sound Processor, Sand Beige recalled by Advanced Bionics.

Reported	Class	Recall	Company	Reason	Where
10 Apr 2019	CLASS II	Na¿da CI Q70 Sound Processor, Sand Beige recalled by Advanced Bionics	Advanced Bionics	Other	NC
10 Apr 2019	CLASS II	Na¿da CI Q90 Sound Processor, Silver Gray recalled by Advanced Bionics	Advanced Bionics	Other	NC

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