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 Adva

Recalled December 26, 2018 · FDA recall Z-0659-2019 · Konica Minolta Healthcare, Americas

Hazard

Unintentional U-Arm movement · FDA Class II

Units

151

Sold at

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.

Description

Unintentional U-Arm movement

Product

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.

Manufacturer(s)

Konica Minolta Healthcare, Americas, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →