CLASS II ONGOING Device recall · Reported 15 Oct 2025 · FDA Enforcement Report

FDR Visionary Suite recalled by FUJIFILM Healthcare Americas

Fujifilm Healthcare Americas is recalling FDR Visionary Suite, distributed in 8 states. The recall was initiated on 15 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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, MP95AA988001, MP95AA988002;

Quantity recalled16 units

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-0044-2026
FDA event ID: 97581
Recalling firm: Fujifilm Healthcare Americas, Lexington, MA
Classification: Class II
Status: Ongoing
Recall initiated: 15 Sep 2025
FDA classified: 7 Oct 2025
Reported: 15 Oct 2025
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

15 Sep 2025	Recall initiated by company
7 Oct 2025	Classified by FDA	+22 days
15 Oct 2025	Published in enforcement report	+8 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 shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

Where it was distributed

Domestic: AK, CA, FL, IL, MA, NH, OH, WI.

Alaska California Florida Illinois Massachusetts New Hampshire Ohio Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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, MP95AA988001, MP95AA988002;

Where was it sold?

Domestic: AK, CA, FL, IL, MA, 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.

More recalls from Fujifilm Healthcare Americas

All 24

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas	Fujifilm Healthcare Americas	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	FDR Visionary Suite recalled by FUJIFILM Healthcare Americas	Fujifilm Healthcare Americas	Other	Nationwide
6 Aug 2025Device	CLASS II	Asprire Cristalle Mammography System recalled	Fujifilm Healthcare Americas	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Synapse PACS recalled by FUJIFILM Healthcare Americas	Fujifilm Healthcare Americas	Device Malfunction	30 states
2 Oct 2024Device	CLASS II	The device is a mobile x-ray system designed to work recalled	Fujifilm Healthcare Americas	Other	Nationwide

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