[pending] FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Pending LLM rewrite. Source: FDA_DEVICE Z-1299-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Category
- Medical Device — Devices
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 Number: CH-200
- (1) Version: 566-16130-23
- UDI-DI: 04540217052226
- Serial numbers: MP95A9F6A001
- MP95A9F6B001
- MP95A9F74001
- MP95A9F74002
- MP95A9F76001
- MP95A9F78001
- (2) Version: 566-16130-31
- UDI-DI: 04540217057436
- Serial numbers: MP95AA783001
- (3) Version: 566-16130-33
- UDI-DI: 04540217057450
- Serial numbers: MP95AA983001
- MP95AA983002
- MP95AA983003
- MP95AA985001
- MP95AA985003
- MP95AA985002
Distribution
Distributed nationwide across the United States.
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