Events

Safety Alert for SONY LMD-1951MD Monitors used with SpyGlass

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

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
    2015-03-12
  • Event Date Posted
    2015-03-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150312a.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
    Medical device safety alert: sony lmd-1951md monitors used with spyglass medical device manufacturer, boston scientific, on behalf of sony electronics inc., has issued a field safety notice concerning specific sony lmd-1951md monitors (material numbers: m00546120, m0054612s0, m0054612z0) used with spyglass. according to the manufacturer, the monitor may either not turn on, or may lose image during use in some situations. the issue is the result of a potential disconnection of the internal power supply caused by a failure of a power board integrated circuit. the failure mode does not occur when an ac adapter is used with the monitor. as a precautionary measure, the manufacturer asks all users to take the following actions. if users possess an ac adapter for each of the affected monitors, use only the ac adaptor when the monitors are in use. users who do not possess an ac adapter for each of the affected monitors should stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented. as a permanent corrective action, the manufacturer will replace the power board of all affected units with a redesigned power board that does not exhibit this failure mode. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 march 2015.

Device

SONY LMD-1951MD Monitors used with SpyGlass
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SONY LMD-1951MD Monitors used with SpyGlass
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH