FDA Device recall Z-2888-2016
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracr…
- FDA Device
- Class II
- terminated
- Published 2016-10-05
On 2016-10-05 the FDA classified a Class II recall of Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracr… by Spiegelberg And Kg, citing 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 meas….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2888-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2009-12-29 |
| Published | 2016-10-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Spiegelberg And Kg |
| Distribution | US |
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
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.
Identifiers
| code_info | Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2888-2016%22
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