The Recall Desk
HighFDA (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.

What this means for you

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: 566-16130-23 566-16130-33
Manufacturer
FUJIFILM Healthcare Americas Corporation
Category
Medical Device — Imaging / Radiography
Hazard
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:

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