Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, RE...
FDA Recall #Z-2888-2016 — Class II — December 29, 2009
Product Description
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.
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.
Recalling Firm
Spiegelberg Gmbh & Co. KG — Hamburg, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22 units
Distribution
Nationwide Distribution to PA only
Code Information
Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated