Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2888-2016 — 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.

U.S. FDA — Device Enforcement · Germany · 2009-12-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2888-2016
Date of alert
2009-12-29
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Spiegelberg Gmbh & Co. KG
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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