FDAFDA · Food and drugs·Recall number Z-1898-2024
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
Published June 5, 2024 · Recall initiated: April 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Distributor
- US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
- Lot
- UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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