High FDA (Devices)·Z-0659-2019·Announced 2018-12-26

Konica Minolta Recalls 151 X-Ray Systems Due to Unintentional Movement

Konica Minolta is recalling 151 Advanced Universal U-Arm 4000 X-ray systems because the U-Arm may move unintentionally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect (unintentional movement) that poses a risk of harm to patients or operators, even though specific injuries are not reported in the source text.

Plain-English summary

Konica Minolta Healthcare, Americas, Inc. is recalling 151 units of the Advanced Universal U-Arm 4000 System. The recall is due to a defect where the U-Arm may move unintentionally.

The affected equipment includes the Bucky Stand SU-4000 and associated subassemblies such as the Vertical Column, Swivel Arm, X-ray Tube, and Image Receptor Assembly. These systems were distributed nationwide in the United States to facilities in 25 states, including Alabama, California, Florida, New York, and Texas.

Healthcare facilities should contact Konica Minolta Healthcare to arrange for the necessary corrective actions. The recall number for this action is Z-0659-2019.

The recalled product

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 T
Manufacturer: Konica Minolta Healthcare, Americas, Inc.
Category: Medical Device — X-Ray Imaging Equipment
Hazard: unintentional-movement
mechanical-defect
Affected units: 151

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

SU41607004
SU41607005
SU41607006
SU41607008
SU41607009
SU41607010
SU41607011
SU41612012
SU41612013
SU41612014
SU41612015
SU41612016
SU41612017
SU41612018
SU41612019
SU41612020
SU41612021
SU41702006
SU41702007
SU41702009

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Same manufacturer · Konica Minolta Healthcare, Americas, Inc.

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