Events

Recall of Device Recall multiple Laser Scanning Microscopes.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zeiss, Carl Inc.

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
    80115
  • Event Risk Class
    Class 2
  • Event Number
    Z-2058-2018
  • Event Initiated Date
    2018-05-08
  • Event Date Posted
    2018-06-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164575
  • 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
    Spectroscopy instrument - Product Code REM
  • Reason
    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.
  • Model / Serial
    Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    USA (nationwide)
  • Product Description
    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
  • Manufacturer Address
    Zeiss, Carl Inc, 1 Zeiss Dr, Thornwood NY 10594-1939
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA