FDA Device recall Z-1898-2024
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremi…
- FDA Device
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremi… by Fujifilm Healthcare Americas, citing bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1898-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-11 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fujifilm Healthcare Americas |
| Distribution | US |
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
Reason
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Identifiers
| code_info | UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95A…UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1898-2024%22
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