Events

Recall of Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Meditec, 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
    59908
  • Event Risk Class
    Class 2
  • Event Number
    Z-3275-2011
  • Event Initiated Date
    2011-09-12
  • Event Date Posted
    2011-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103973
  • 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
    Microscope, surgical - Product Code EPT
  • Reason
    Some third party surgical drapes have optically active protective lenses that could affect the zeiss surgical microscope position information that is passed on to third party navigation systems.
  • Action
    The firm, Zeiss, sent an "IMPORTANT SAFETY ALERT FOR ZEISS SURGICAL MICROSCOPES" letter dated September 7, 2011, to all affected customers. The letter described the product, problem and action to be taken. The customers were instructed to use surgical drapes compatible with ZEISS surgical microscopes and always follow the instructions for use of the third party navigation system manufacturer for calibration, calibration verification and operation. In addition, the firm supplied customers with a supplement to their Zeiss surgical microscope user documentation and requested that they read the information and keep a copy with their original instructions also the customers were instructed to complete and return the Acknowledgement of Receipt form within 5 business days via fax to 1-866-809-6044 or USPS to Stericycle, Inc., Attn: Event 2480, 2670 Executive Dr. Suite A, Indianapolis, IN 46241. Should you have any questions about this Safety Alert, please contact your Carl Zeiss Customer Care representative at 1-888-871-7120.

Device

Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro
  • Model / Serial
    All-OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4,  OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA only.
  • Product Description
    OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, || OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4, || OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount. || A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.
  • Manufacturer
    Carl Zeiss Meditec, Inc.

Manufacturer

Carl Zeiss Meditec, Inc.
  • Manufacturer Address
    Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin CA 94568-7562
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA