Class II — Spiegelberg Gmbh & Co. KG
| Recalling firm | Spiegelberg GmbH & Co. KG |
|---|---|
| Registered facility | SPIEGELBERG GmbH & Co. KG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 22 units |
| Distribution | Nationwide Distribution to PA only |
| Initiated | 2009-12-29 |
| Classified | 2016-09-26 |
| Terminated | 2016-10-05 |
| Recall number | Z-2888-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spiegelberg Gmbh & Co. KG (Z-2888-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75160/
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