X-ray imaging equipment recalled for potentially defective mounting shaft
FUJIFILM Healthcare's FDR Visionary Suite X-ray equipment may have a defective mounting shaft that can break, potentially compromising protective equipment functionality. Sixteen units were distributed across eight states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a structural failure risk that could compromise radiation protection during operation. No injuries or illnesses have been reported, meeting the criterion for Score 3 (High)—risk-of-harm products where injury has not yet been reported.
Plain-English summary
FUJIFILM Healthcare Americas Corporation is recalling 16 units of the FDR Visionary Suite, CH-200 X-ray imaging system. Three model versions are affected: 566-16130-23, 566-16130-31, and 566-16130-33.
The shaft that mounts the X-ray tube unit to the support structure may break. When this occurs during operation—particularly when the equipment is tilted forward while being lifted—the protective parts may not work effectively, potentially allowing unintended X-ray exposure.
The affected units were distributed domestically to healthcare facilities in Alaska, California, Florida, Illinois, Massachusetts, New Hampshire, Ohio, and Wisconsin. No injuries have been reported. Customers should contact FUJIFILM Healthcare Americas Corporation using their equipment's serial number to verify if their unit is affected and to arrange repair or replacement.
The recalled product
- Product
- FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Hazard
- structural-failure
- radiation-exposure-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Version Number: (1) 566-16130-23
- (2) 566-16130-31
- (3) 566-16130-33
- UDI-DI: (1) 04540217052226
- (2) 04540217057436
- (3) 04540217057450
- Serial Numbers: (1) MP95A8F5A001
- MP95A9F6A001
- MP95A9F6B001
- MP95A9F74001
- MP95A9F74002
- MP95A9F76001
- MP95A9F78001
- (2) MP95AA783001
- (3) MP95AA983001
- MP95AA983002
- MP95AA983003
- MP95AA985001
- MP95AA985003
- MP95AA985002
Distribution
Distributed in 8 states:
- AK
- CA
- FL
- IL
- MA
- NH
- OH
- WI
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