The device is an X-ray system that is capable of radiographic and… — Class II medical device recall Z-1154-2024
Ongoing recall by Canon Medical System, USA, INC., reported 2024-02-28, distributed in CA, LA. VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal b
| Recall number | Z-1154-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | CA, LA |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 04987670100192 |
| Serial numbers | B1E22X2005 |
Product
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
Reason for recall
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1154-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.