Events

Safety Alert for Intraoral camera

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by MP Manufacturer Unknown Sender: Ningho Cristofoli Medical Equipment Co. Ltd., China.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    1
  • Date
    2016-02-08
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
  • Extra notes in the data
  • Reason
    Neither the instructions for use nor the packaging bear the ce conformity marking. there is no information on the manufacturer on the medical device or on the packaging of the product, and there is no data on the manufacturer's authorized representative in the european economic area. it is necessary to identify the medical device on the medical device, which is not specified on the medical device itself. the medical device packaging does not include the serial no.
  • Action
    Disallowed to market

Device

Intraoral camera

Manufacturer

MP Manufacturer Unknown Sender: Ningho Cristofoli Medical Equipment Co. Ltd., China
  • Manufacturers representative
    MEDICA by Egidijus Navickas
  • Source
    MH