Agency classClass IIOur severity:High FDA (Devices)·Z-1898-2024·Announced 2024-06-05

Radiographic imaging system tubes may fall due to bolt rupture

FUJIFILM's FDR Visionary Suite radiographic imaging system has bolts that may rupture due to fatigue, potentially causing the tube support to fall and injure patients. The recall affects 18 units distributed across nine states.

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: This is a Class II FDA recall involving a structural defect that could result in patient injury from falling equipment. No injuries or deaths have been reported. The hazard is significant but theoretical, falling under 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

FUJIFILM Healthcare Americas Corporation is recalling the FDR Visionary Suite radiographic imaging system due to a structural defect in the CH-200 tube assembly. Bolts on the tube support may rupture as a result of fatigue failure, which could cause the tube support to fall.

This defect poses a risk of patient injury. The recall affects 18 units that were distributed nationwide across Alaska, California, Florida, Illinois, Nebraska, New Hampshire, Ohio, Tennessee, and Wisconsin. The affected models are catalog numbers 566-16130-23 and 566-16130-33.

The recall was initiated by FUJIFILM Healthcare Americas Corporation. Healthcare facilities with affected units should contact the manufacturer for further information and instructions on corrective action.

The recalled product

Product: 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…
Manufacturer: FUJIFILM Healthcare Americas Corporation
Category: Medical Device — Imaging / Radiography
Hazard: structural-failure
fall-hazard
injury-risk
Affected units: 18

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 (18)

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

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Same manufacturer · FUJIFILM Healthcare Americas Corporation

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