Device recall
Z-1207-2019: OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers…
FDA device recall · Class II · Carestream Health, Inc.
Key facts
| Recall number (Z-number) | Z-1207-2019 |
|---|---|
| Recall event | 82491 |
| Product | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric… |
| Product code | JAK |
| Recalling firm | Carestream Health, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2020 |
| 510(k) numbers | K173478 |
| FEI number | 1317307 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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