Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1299-2026 — FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

U.S. FDA — Device Enforcement · United States · 2026-01-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1299-2026
Date of alert
2026-01-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
FUJIFILM Healthcare Americas Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04540217052226
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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