Device recall
Z-0176-2020: Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0176-2020 |
|---|---|
| Recall event | 83978 |
| Product | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER… |
| Product code | LMA |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 25, 2024 |
| FEI number | 3002619595 |
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