fda
10 records
FDA Device Recall: HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
2025-05-28
Class II — Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
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FDA Recall: Advanced Bionics, LLC — Class III
20201202
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. | Product: AB PowerCel 170 (velvet black), REF: CI-5517-150, UD...
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FDA Device Recall: AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used
2020-12-02
Class III — Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
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FDA Device Recall: AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used
2020-12-02
Class III — Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
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FDA Device Recall: SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, U
2020-03-11
Class III — The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. T...
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FDA Device Recall: HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF C
2020-02-26
Class III — Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medi...
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FDA Recall: Advanced Bionics, LLC — Class II
20190410
The sound processors were loaded with the incorrect firmware. | Product: Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Vel
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FDA Device Recall: Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model
2019-04-10
Class II — The sound processors were loaded with the incorrect firmware.
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FDA Device Recall: Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
2019-04-10
Class II — The sound processors were loaded with the incorrect firmware.
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FDA Device Recall: Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model
2019-04-10
Class II — The sound processors were loaded with the incorrect firmware.
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nppes
1 records
ny_medicaid
1 records
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