Events

Safety Alert for ManoShield™ AR

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Sierra Scientific Instruments.

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
  • Date
    2011-12-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111228.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: sierra scientific instruments manoshield™ ar medical device manufacturer, sierra scientific instruments, is conducting a product recall for manoshield™ ar, part number mss-3599. the lot numbers affected are listed below: lot number f1114619ua f1114625ua f1115402ua f1123703ua f1128101ua f1114620ua f1114626ua f1121304ua f1124202ua f1129701ua f1114621ua f1114627ua f1123405ua f1125201ua f1130202ua the recall is initiated because of quality defects found on some lots of the products. the, defects occurred during normal use, and were noted when product was used in a manner that was not supported by its design specification and tolerances. according to the local supplier, products with the affected lot numbers have not been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

ManoShield™ AR
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sierra Scientific Instruments ManoShield™ AR
  • Manufacturer
    Sierra Scientific Instruments

Manufacturer

Sierra Scientific Instruments
  • Manufacturer Parent Company (2017)
    Medtronic Plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH