Device recall
Z-2134-2014: Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-2134-2014 |
|---|---|
| Recall event | 68737 |
| Product | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file… |
| 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