FDA Device recall Z-2655-2017
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images o…
- FDA Device
- Class II
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class II recall of SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images o… by Shimadzu Medical Systems Usa Com, citing cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2655-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-23 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Shimadzu Medical Systems Usa Com |
| Distribution | US |
Product
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
Reason
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Identifiers
| code_info | Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2655-2017%22
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