X-ray systems recalled over welded contactor contacts that may overheat
FUJIFILM Healthcare Americas is recalling 16 FDR Visionary Suite systems because welded contactor contacts may keep supplying current after the device is switched off.
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: the firm states the circuit may overheat, damage surrounding parts and cause smoke, and no injuries are reported.
Plain-English summary
The FDR Visionary Suite, model number CH-200, is being recalled by FUJIFILM Healthcare Americas Corporation, covering the software versions listed in the enforcement record.
The record states 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. The record states that as a result it cannot be denied that the circuit in question overheats and damages the surrounding parts, and that it may also cause smoke.
The record lists 16 units under model CH-200, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was nationwide in the United States, in Alaska, California, Connecticut, Florida, Illinois, New Hampshire, Ohio and Wisconsin. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow FUJIFILM's instructions.
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 — X-ray system
- 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 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
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