Ziehm Imaging Inc recalls Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

Recall date

February 23, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1893-2017

FDA classification

Class II

Brand / firm

Ziehm Imaging Inc

Sold / distributed

US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.

Why it was recalled

During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component

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

What was recalled

Ziehm Imaging solo FD Mobile Fluoroscopic C-arm