Medical device recalls Moderate risk

Toshiba American Medical Systems Inc recalls INFX-8000F Fluoroscopic X-Ray Systems

Recall date
December 29, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0842-2018
FDA classification
Class II
Brand / firm
Toshiba American Medical Systems Inc
Sold / distributed
United States

Why it was recalled

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

INFX-8000F Fluoroscopic X-Ray Systems

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