Device recall
Z-2888-2016: Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P…
FDA device recall · Class II · Spiegelberg Gmbh & Co. KG
Key facts
| Recall number (Z-number) | Z-2888-2016 |
|---|---|
| Recall event | 75160 |
| Product | Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head. |
| Product code | GWM |
| Recalling firm | Spiegelberg Gmbh & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2016 |
| 510(k) numbers | K003759 |
| FEI number | 3002108226 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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