Recall Z-2888-2016 ยท GWM Device, Monitoring, Intracranial Pressure
Spiegelberg Gmbh & Co. KG
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.
| Date | Dec 29, 2009 |
| Status | Terminated |
| Reason | In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg. |
| Root cause | Packaging |
| Action | Spiegelberg Gmbh & Co. KG sent an Urgent Medical Device Recall letter dated December 29, 2009, to all affected customers. Customers were instructed to quarantine and return stored products. Furthermore, they were asked to inform all their customers which have received the affected products and recall the products accordingly. Furthermore, they were asked to tell us about the actions taken by them. |
| Quantity | 22 units |
| Distribution | Nationwide Distribution to PA only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003759 | AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR Aesculap, Inc., Jun 28, 2001 |