FDA Device recall Z-0659-2019
Bucky Stand SU-4000 Input 2017.11.17
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Bucky Stand SU-4000 Input 2017.11.17 by Konica Minolta Healthcare Americas, citing unintentional U-Arm movement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0659-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-08 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Konica Minolta Healthcare Americas |
| Distribution | US |
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.
Reason
Unintentional U-Arm movement
Identifiers
| code_info | SU4000 AU 4000 U ARM Item Number DR-4000-MTB Serials Numbers/Lot Numbers: SU41607003; SU41607004; SU41607005; SU41…SU4000 AU 4000 U ARM Item Number DR-4000-MTB Serials Numbers/Lot Numbers: SU41607003; SU41607004; SU41607005; SU41607006; SU41607008; SU41607009; SU41607010; SU41607011; SU41612012; SU41612013; SU41612014; SU41612015; SU41612016; SU41612017; SU41612018; SU41612019; SU41612020; SU41612021; SU41702006; SU41702007; SU41702009; SU41703010; SU41703011; SU41703012; SU41703013; SU41703015; SU41704016; SU41704017; SU41704019; SU41704020; SU41704021; SU41704022; SU41704023; SU41704024; SU41704025; SU41705026; SU41705027; SU41705028; SU41705029; SU41705031; SU41705032; SU41705033; SU41705034; SU41705035; SU41707036; SU41707038; SU41707039; SU41707040; SU41707041; SU41707042; SU41707043; SU41707044; SU41708046; SU41708047; SU41708048; SU41708049; SU41708050; SU41708051; SU41708052; SU41708053; SU41708054; SU41708055; SU41709060; SU41709061; SU41709062; SU41709063; SU41709064; SU41709065; SU41709066; SU41709068; SU41709069; SU41711070; SU41711071; SU41711072; SU41711073; SU41711074; SU4171107 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0659-2019%22
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