Device recall
Z-0400-2016: Brilliance CT (computed tomography) scanners, Big Bore configuration, Model…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-0400-2016 |
|---|---|
| Recall event | 69121 |
| Product | Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body. |
| Product code | JAK |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2015 |
| 510(k) numbers | K033357 |
| FEI number | 1525965 |
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