Z-2888-2016Class II

Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF...

Name: Z-2888-2016 Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF...
Creator: Spiegelberg Gmbh & Co. KG
Published: 2009-12-29
License: https://open.fda.gov/license/

SPIEGELBERG GmbH & Co. KG / initiated 2009-12-29 / Terminated / root cause: packaging

FDA source

Spiegelberg Gmbh & Co. KG began a recall of Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure... on 2009-12-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2888-2016
Classification: Class II
Status: Terminated
Initiated: 2009-12-29
Posted: 2016-09-26
Terminated: 2016-10-05
Recalling firm: SPIEGELBERG GmbH & Co. KG
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.
Product code: GWM Device, Monitoring, Intracranial Pressure
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Spiegelberg Gmbh & Co. KG sent an Urgent Medical Device Recall letter dated December 29, 2009, to all affected customers. Customers were instructed to quarantine and return stored products. Furthermore, they were asked to inform all their customers which have received the affected products and recall the products accordingly. Furthermore, they were asked to tell us about the actions taken by them.
Quantity in commerce: 22 units
Distribution: Nationwide Distribution to PA only
Product codes and lots: Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2888-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2888-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-26

Product code GWM

K003759Class IIAesculap Spiegelberg Brain Pressure MonitorAesculap, Inc. / cleared 2001-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)