Events

Rappel de Device Recall multiple Laser Scanning Microscopes.

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 Zeiss, Carl Inc.

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
    80115
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2058-2018
  • Date de mise en oeuvre de l'événement
    2018-05-08
  • Date de publication de l'événement
    2018-06-09
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164575
  • 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
    Spectroscopy instrument - Product Code REM
  • Cause
    In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the class i limit.
  • Action
    1.Your firm will send an initial email to all known users advising them of the issue, the risk involved and associated mitigations until the units can be evaluated by Carl Zeiss service representatives, 2.Your firm will send a second written communication to each first line purchaser and to each known user site with the notice of action and warning to discontinue use of the component until it has been verified as defective or properly functioning, and 3.Your firm will dispatch factory trained service representatives to perform verification tests and to replace defective units as necessary, free of charge. CDRH approves the CAP subject to the following conditions: For further questions, please call (914) 747-1800.. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Corrective actions will be provided at no cost to the purchasers and completed by March 1, 2019.

Device

Device Recall multiple Laser Scanning Microscopes.
  • Modèle / numéro de série
    Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide)
  • Description du dispositif
    Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple || Laser Scanning Microscopes. || Laser scanning microscopes are used in cell biology research.
  • Manufacturer
    Zeiss, Carl Inc

Manufacturer

Zeiss, Carl Inc
  • Adresse du fabricant
    Zeiss, Carl Inc, 1 Zeiss Dr, Thornwood NY 10594-1939
  • Société-mère du fabricant (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA