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.
FDA Recall Z-2888-2016 · Posted None
Recalling FirmSpiegelberg Gmbh & Co. KG
Recall StatusTerminated
Product CodeGWM
Date Initiated2009-12-29
Date Terminated2016-10-05
Product Quantity22 units
Reason for Recall
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.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Nationwide Distribution to PA only
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.