Device recall
Z-0218-2016: Digital Lightbox, BrainLAB system, image processing, radiological Product Usage…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0218-2016 |
|---|---|
| Recall event | 72236 |
| Product | Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media… |
| Product code | LLZ |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2017 |
| 510(k) numbers | K093117 |
| FEI number | 3002619595 |
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