Device recall
Z-0659-2019: Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name…
FDA device recall · Class II · Konica Minolta Healthcare, Americas, Inc.
Key facts
| Recall number (Z-number) | Z-0659-2019 |
|---|---|
| Recall event | 81649 |
| 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… |
| Product code | IXY |
| Recalling firm | Konica Minolta Healthcare, Americas, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 23, 2021 |
| FEI number | 3002885429 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database