Medical X-Ray Imaging System Recalled for Device Malfunction
The CS 9600 X-ray imaging system manufactured by Trophy SAS has been recalled worldwide due to failure to function as intended and non-conformance to design specifications. Approximately 895 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall, which indicates a reasonable probability that use of the device will cause serious adverse health consequences. Although no injuries have been reported, the device's failure to function as intended presents a risk of harm to patients relying on accurate diagnostic imaging.
Plain-English summary
The CS 9600 is an extraoral X-ray system manufactured by Trophy SAS intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose, and Throat), cervical spine, and wrist regions. The system is used by healthcare professionals as diagnostic support for pediatric and adult patients.
The device is being recalled because it failed to function as intended and/or failed to conform to design specifications. The specific nature of the malfunction or non-conformance has not been detailed in the recall notice.
Approximately 895 units of the CS 9600 have been distributed worldwide and are included in this recall.
Healthcare facilities and providers in possession of affected units should discontinue use and contact Trophy SAS for further instructions regarding the recall.
The recalled product
- Product
- CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿a…
- Manufacturer
- Trophy SAS
- Affected units
- 895
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CS 9600
Distribution
Distribution scope not specified by the agency.
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