Events

Safety Alert for RF 3000 device

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
    2018-02-06
  • Event Date Posted
    2018-02-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180206b.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: boston scientific, rf 3000 device medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its rf 3000 device [upn:6221 (m001262210); serial number: 11414007 ,11414008 , 11414009 ,11414010 , 11414012 , 11414013 ,11414019, 11414020, 11414021 ,11414022, 11414023 , 11414024 ,11414026, 11414027, 1414028, 11414029, 11414030, 81213006, 81213007, 121313001, 121313002 ,121313004, 121313005 ,121313006 , 121313008 ,121313010 ,121313011, 121313013 , 121313014,121313015 , 121313016, 121313017, 121313019 , 121313020, 121313021, 121313022]. the manufacturer has identified that rf 3000 fuse information on the label is incomplete with ‘l’ missing which stands for ‘low capacity break’. the fuse information on the label is ‘220-240v~ 250v, t3.15a’, while it should be ‘220-240v~ 250v, t3.15al’. the fuse information in the dfu is ‘220-240v~: t3, 15al 250v, 5x20 mm’ is correct. according to the manufacturer, the field action is only related to the chinese label over-labeling process. no other products or countries are affected by this action. there have been no complaints or adverse events reported to the manufacturer for this labeling discrepancy the affected customers will be contacted to arrange an onsite service to over label the chinese label on their rf 3000. according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february, 2018.

Device

RF 3000 device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific, RF 3000 device
  • 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