Spiegelberg Brain Pressure Monitoring System Probe 3PN — Class II medical device recall Z-2888-2016
Terminated recall by Spiegelberg Gmbh & Co. KG, reported 2016-10-05, distributed nationwide. In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred.
| Recall number | Z-2888-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spiegelberg Gmbh & Co. KG, Hamburg, N/A, Germany |
| Recall initiated | 2009-12-29 |
| Classified | 2016-09-26 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2016-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| Model numbers | SNDI3.1.531FV534P, SNDI3.1.63/FV535P |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2888-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.