Konica Minolta Healthcare, Americas, Inc. recalls Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced…

Recall date

November 8, 2018

Source

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

Recall number

Z-0659-2019

FDA classification

Class II

Brand / firm

Konica Minolta Healthcare, Americas, Inc.

Sold / distributed

US Nationwide Distribution: AL; CA; CO; FL; GA; IA; IL; IN; KY; LA; MA; MI; MN; MO; NC; NH; NY; OH; OK; PA; SC; TN; TX; and VA.

Why it was recalled

Unintentional U-Arm movement

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

What was recalled

Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.