Events

Recall of Device Recall Intracranial pressure monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spiegelberg Gmbh & Co. KG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75160
  • Event Risk Class
    Class 2
  • Event Number
    Z-2888-2016
  • Event Initiated Date
    2009-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149491
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, monitoring, intracranial pressure - Product Code GWM
  • 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.
  • 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.

Device

Device Recall Intracranial pressure monitor
  • Model / Serial
    Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393;  Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to PA only
  • 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.
  • Manufacturer
    Spiegelberg Gmbh & Co. KG

Manufacturer

Spiegelberg Gmbh & Co. KG
  • Manufacturer Address
    Spiegelberg Gmbh & Co. KG, Tempowerkring 4, Hamburg Germany
  • Manufacturer Parent Company (2017)
    Spiegelberg GmbH & Co. KG
  • Source
    USFDA