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Open, Classified

CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.

FDA Recall Z-1627-2023 · Posted 2023-05-27

Recalling FirmTrophy SAS
Recall StatusOpen, Classified
Product CodeOAS
Date Initiated2021-07-21
Product Quantity895 units

Reason for Recall

Device failed to function as intended and/or failed to conform to their design specifications.

Firm Action

The letter identified the affected product, problem and actions to be taken.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200183CS 9600Trophy · 2020-03-13K181136CS 9600Trophy · 2018-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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