Fujifilm FDR Visionary Suite X-ray Tube Recall for Cracking Risk
Fujifilm is recalling three FDR Visionary Suite systems because cracks may develop in the X-ray tube holding shaft, posing a potential safety issue.
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: The recall involves a structural defect in a medical device (cracking shaft) which poses a risk of harm, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling three units of the FUJIFILM FDR Visionary Suite with CH-200. The FDR Visionary Suite is a digital radiography system intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts. The specific issue involves the X-ray tube ceiling unit CH-200.
The recall is due to a potential issue where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. The X-ray tube assembly is mounted to this flange, which is part of the tube holding shaft. This defect could compromise the structural integrity of the mounting system.
The recall affects three units distributed in the United States. The specific serial numbers for the affected systems are MP95A9F6B001, MP95A9F6A001, and MP95A8F5A001. Users of these devices should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to address the potential cracking issue.
The recalled product
- Product
- FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Affected units
- 3
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 (2)
- UDI: (01)04540217052226(21)MP95A9F6B001
- (01)04540217052226(21)MP95A9F6A001
Distribution
Distribution scope not specified by the agency.
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