Bucky Stand SU-4000 Input 2017 — Class II medical device recall Z-0659-2019
Terminated recall by Konica Minolta Healthcare, Americas, Inc., reported 2018-12-26, distributed nationwide. Unintentional U-Arm movement
| Recall number | Z-0659-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Konica Minolta Healthcare, Americas, Inc., Garner, NC, United States |
| Recall initiated | 2018-11-08 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2021-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 151 |
| 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 and 112 more |
| Model numbers | DR-4000-MTB |
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 for recall
Unintentional U-Arm movement
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0659-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.