Official recall record
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-15
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04987670100192
- Brand on record
- Canon Medical System, USA, INC.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2022-05-03 · US FDA — Medical Devices
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, IN - 2026-10-12 · US FDA — Medical Devices
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
Other recalls from this brand
- 2025-12-19 · US FDA — Medical Devices
Alphenix INFX-8000F, interventional fluoroscopic x-ray system - 2025-12-19 · US FDA — Medical Devices
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 - 2025-12-19 · US FDA — Medical Devices
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
All 10 official recall notices naming Canon Medical System, USA, INC. on this site →