Events

Rappel de Device Recall Intracranial pressure monitor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spiegelberg Gmbh & Co. KG.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75160
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2888-2016
  • Date de mise en oeuvre de l'événement
    2009-12-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149491
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Device, monitoring, intracranial pressure - Product Code GWM
  • Cause
    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
  • Modèle / numéro de série
    Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393;  Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to PA only
  • Description du dispositif
    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
  • Adresse du fabricant
    Spiegelberg Gmbh & Co. KG, Tempowerkring 4, Hamburg Germany
  • Société-mère du fabricant (2017)
    Spiegelberg GmbH & Co. KG
  • Source
    USFDA