Spiegelberg Gmbh & Co. KG recalls Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Pr…

Recall date

December 29, 2009

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2888-2016

FDA classification

Class II

Brand / firm

Spiegelberg Gmbh & Co. KG

Sold / distributed

Nationwide Distribution to PA only

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.