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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Konica Minolta Healthcare, Americas, Inc.
- 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
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