Spiegelberg Brain Pressure Monitoring Probes Recalled for Measurement Errors
Spiegelberg is recalling 22 Brain Pressure Monitoring System probes due to air chamber shrinkage that caused false high readings in the lower measuring range.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that causes inaccurate readings (false high values), which poses a risk of harm to patients if relied upon for clinical decisions, but no injuries or illnesses have been reported.
Plain-English summary
Spiegelberg Gmbh & Co. KG is recalling 22 units of the Spiegelberg Brain Pressure Monitoring System, specifically Probe 3PN (REF: SNDI3.1.531FV534P) and Probe 3PS (REF: SNDI3.1.63/FV535P). These intracranial pressure measuring probes are used to monitor pressure within the head.
The recall was initiated because a shrinkage of the air chamber occurred during sterilization in the vast majority of the specified products. This defect resulted in false high readings in the lower measuring range of 0 to 20 mmHg. The measurement error was most significant at the lowest end of the range, reaching up to 8 mmHg.
The affected units were distributed nationwide to Pennsylvania only. Specific serial numbers for the recalled probes are listed in the agency documentation. Users should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- Spiegelberg Gmbh & Co. KG
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393
- Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
Distribution
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