Recall Z-1898-2024— FUJIFILM Healthcare Americas Corporation
Class II · Ongoing
Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2024-04-11. It names one FDA 510(k) clearance: K152294. 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.
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-11
- Firm location
- Lexington, MA, 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
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 for recall
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Data sourced from openFDA. This site is unofficial and independent of the FDA.