CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report

FDR Visionary Suite - Intended to generate digital recalled

Fujifilm Healthcare Americas is recalling FDR Visionary Suite - Intended to generate digital or conventional radiographic images of, distributed nationwide in the US. The recall was initiated on 11 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

Quantity recalled18 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-1898-2024
FDA event ID: 94443
Recalling firm: Fujifilm Healthcare Americas, Lexington, MA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Apr 2024
FDA classified: 24 May 2024
Reported: 5 Jun 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

11 Apr 2024	Recall initiated by company
24 May 2024	Classified by FDA	+43 days
5 Jun 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

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 - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

Where it was distributed

US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.

Nationwide Alaska California Florida Illinois Nebraska New Hampshire Ohio Tennessee Wisconsin

Questions about this recall

Why was it recalled?

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

Which lots are affected?

UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

Where was it sold?

US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, 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
15 Oct 2025Device	CLASS II	FDR Visionary Suite recalled by FUJIFILM Healthcare Americas	Fujifilm Healthcare Americas	Device Malfunction	8 states
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

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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide