Z-1898-2024 Class II Ongoing
FDA device recall Z-1898-2024 was initiated by FUJIFILM Healthcare Americas Corporation on April 11, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2024
- Initiation Date
- April 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
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
Distribution Pattern
US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
Code Information
UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002