Events

Safety Alert for Ultrasonic Probe Type Ultrasound Scanner

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by MP Manufacturer Unknown Sender SonoStar Technological 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
    2016-02-26
  • 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
    1. there is no information necessary to identify the medical device and the contents of the packaging (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.2). 2. the ce marking and the number of the notified body shall not be affixed to the medical device or to the packaging of the medical device (not in accordance with mn 4: 2009 38, 39 and 40). 3. there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with mn 4: 2009, annex 1, clause 14.3.1). 4. no model, batch / serial number (does not meet mn 4: 2009 requirements 14.3.4). 5. no information is available on the safe and proper use of the medical device (not in accordance with mn 4: 2009 annex 1, clause 14.1).
  • Action
    Disallowed to market

Device

Ultrasonic Probe Type Ultrasound Scanner

Manufacturer

MP Manufacturer Unknown Sender SonoStar Technological Co., Ltd., China
  • Manufacturers representative
    JSC "Hisas"
  • Source
    MH