Spiegelberg Gmbh & Co. KG: Medical Device Recall in 2016 - (Recall #: Z-2888-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 29, 2009

Date Posted: October 5, 2016

Recall Number: Z-2888-2016

Event ID: 75160

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.

Status: Terminated

Product Quantity: 22 units

Code Information:

Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122

Distribution Pattern:

Nationwide Distribution to PA only

Voluntary or Mandated:

Voluntary: Firm initiated