Events

Recall of OPMI Pentero C

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
    65109
  • Event Risk Class
    Class 2
  • Event Number
    Z-1440-2013
  • Event Initiated Date
    2013-04-18
  • Event Date Posted
    2013-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117898
  • 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
    Carl zeiss meditec is conducting a field corrective action for its opmi pentero c surgical microscope system. during a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.
  • Action
    Carl Zeiss Meditec, Inc sent a Customer Notification letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that firm's sales representative will be scheduling an on-site visit, informing them of the affected product and providing instructions on the recall. For question call 925-580-5371.

Device

OPMI Pentero C
  • Model / Serial
    Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), || Product Usage: || A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
  • 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