Recall Z-0232-2018— Fujifilm Medical Systems U.S.A., Inc.
Class II · Terminated
Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2017-06-15, terminated 2018-05-09. It names one FDA 510(k) clearance: K152294. Product: FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is 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.. Reason: A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange..
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-15
- Terminated
- 2018-05-09
- Firm location
- Stamford, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is 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.
Reason for recall
A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Data sourced from openFDA. This site is unofficial and independent of the FDA.