Class II — Konica Minolta Healthcare, Americas, Inc.
| Recalling firm | Konica Minolta Healthcare Americas, Inc. |
|---|---|
| Registered facility | Konica Minolta Healthcare Americas, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 151 |
| Distribution | 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. |
| Initiated | 2018-11-08 |
| Classified | 2018-12-20 |
| Terminated | 2021-07-23 |
| Recall number | Z-0659-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Konica Minolta Healthcare, Americas, Inc. (Z-0659-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81649/
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