Z-1627-2023Class II

CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxi...

Name: Z-1627-2023 CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxi...
Creator: Trophy SAS
Published: 2021-07-21
License: https://open.fda.gov/license/

Trophy / initiated 2021-07-21 / Open, Classified / root cause: design

FDA source

Trophy SAS began a recall of CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwr... on 2021-07-21. FDA classified it as Class II and gives the reason as "Device failed to function as intended and/or failed to conform to their design specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1627-2023
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-21
Posted: 2023-05-27
Recalling firm: Trophy
Product: CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.
Product code: OAS X-Ray, Tomography, Computed, Dental
Reason for recall: Device failed to function as intended and/or failed to conform to their design specifications.
Root cause tag: design
FDA root cause: Radiation Control for Health and Safety Act
Action: The letter identified the affected product, problem and actions to be taken.
Quantity in commerce: 895 units
Distribution: Worldwide Distribution
Product codes and lots: CS 9600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1627-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1627-2023	Class II	Ongoing	FDA Mandated	2023-06-07	2023-05-26

Product code OAS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)