SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catheri

Hazard

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

Details from the source

Reason for recall: If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button. Distribution: US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN. Quantity: 13 Lot/code info: UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.

UPC codes

04540217058327, 04540217049066, 04540217058143

Source

Official record: FDA (Device enforcement) ↗

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