Recall Z-2888-2016— Spiegelberg Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Spiegelberg Gmbh & Co. KG, initiated 2009-12-29, terminated 2016-10-05. It names one FDA 510(k) clearance: K003759. Product: 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: 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
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2009-12-29
- Terminated
- 2016-10-05
- Firm location
- Hamburg, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.