FUJIFILM Healthcare Americas Corporation: FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

Hazard

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Details from the source

Reason for recall: It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting. Distribution: Domestic: AK, CA, FL, IL, MA, NH, OH, WI. Quantity: 16 units Lot/code info: Model/Version Number: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33; UDI-DI: (1) 04540217052226, (2) 04540217057436, (3) 04540217057450; Serial Numbers: (1) MP95A8F5A001, MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001, (2) MP95AA783001, (3) MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;

UPC codes

04540217052226, 04540217057436, 04540217057450

Source

Official record: FDA (Device enforcement) ↗

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