FDA-Device2016-10-05Class II
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.
Spiegelberg Gmbh & Co. KG
Hazard
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.
Sold states
Nationwide Distribution to PA only
Affected count
22 units
Manufactured in
Tempowerkring 4, N/A, Hamburg, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2888-2016Don't want to check this manually?
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