FUJIFILM Healthcare Americas Corporation: FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other bod

Hazard

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

Details from the source

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: US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI. Quantity: 18 units Lot/code info: UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

UPC codes

04540217052226, 04540217057450

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.