The INFX-8000F is designed to take advantage of the latest… — Class II medical device recall Z-1155-2024
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-1155-2024 |
|---|---|
| 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 | 2 |
| UPC / GTIN / UDI-DI | 04987670100208 |
| Serial numbers | BGE2292016, BGE2362017 |
Product
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
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-1155-2024. 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.