CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report
FDR Visionary Suite recalled by FUJIFILM Healthcare Americas
Fujifilm Healthcare Americas is recalling FDR Visionary Suite, distributed nationwide in the US. The recall was initiated on 9 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1299-2026
- FDA event ID
- 98124
- Recalling firm
- Fujifilm Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2026
- FDA classified
- 5 Feb 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2026 | Recall initiated by company | |
| 5 Feb 2026 | Classified by FDA | +27 days |
| 11 Feb 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Where it was distributed
US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
Nationwide AlaskaCaliforniaConnecticutFloridaIllinoisNew HampshireOhioWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, MP95AA988001, MP95AA988002;
Where was it sold?
US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Labeling Errors | Nationwide |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 8 states |
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| Device | CLASS II | Synapse PACS recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 30 states |
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