Radiography suites recalled because X-ray tube mounting shaft may break
FUJIFILM is recalling 16 FDR Visionary Suite systems because the shaft mounting the X-ray tube unit on the support may break, with protective parts possibly not working.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a mounting shaft that can break while supporting an X-ray tube is a physical hazard, and no injuries are reported.
Plain-English summary
FDR Visionary Suite, CH-200, model/version numbers 566-16130-23, 566-16130-31 and 566-16130-33, are being recalled.
It was found that the shaft for mounting the X-ray tube unit on the support may break. It was also found that the protective parts might not work effectively, but only when the shaft was broken while being operated toward the front while lifting.
The recall covers 16 units, distributed in Alaska, California, Florida, Illinois, Massachusetts, New Hampshire, Ohio and Wisconsin. The FDA has classified the action as Class II.
The enforcement record describes the mechanical failure mode and reports no injuries. Sites operating affected systems should follow FUJIFILM's instructions.
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
- Affected units
- 16
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
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