The Recall Desk
HighFDA (Devices)·Z-2888-2016·Announced 2016-10-05

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.

What this means for you

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
Category
Medical Device — Intracranial Pressure Monitor
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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