Official recall record
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-01-09
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04540217052226
- Brand on record
- FUJIFILM Healthcare Americas Corporation
What the authority reported
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
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.
- 2017-06-15 · US FDA — Medical Devices
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visi - 2024-04-11 · US FDA — Medical Devices
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che
Other recalls from this brand
- 2024-01-03 · US FDA — Medical Devices
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical