FDAFDA · Food and drugs·Recall number 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.
Published October 5, 2016 · Recall initiated: December 29, 2009
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spiegelberg Gmbh & Co. KG
- Distributor
- Nationwide Distribution to PA only
- Lot
- Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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