FDA Medical Device Recalls (openFDA)
Trophy SAS: CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.
- Recall number
- Z-1627-2023
- Recalling firm
- Trophy SAS
- Product
- CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.
- Status
- Open, Classified
- Initiated
- 2021-07-21
- Posted
- 2023-05-27
- Terminated
- not on file
- Reason
- Device failed to function as intended and/or failed to conform to their design specifications.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The letter identified the affected product, problem and actions to be taken.
- Quantity
- 895 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- CS 9600
- 510(k) numbers
- ["K181136","K200183"]
- PMA numbers
- not on file
- Product code
- OAS
- Firm FEI
- 7695
- Firm city
- Marne
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28