Events

Safety Alert for SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System

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

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
    2015-06-24
  • Event Date Posted
    2015-06-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150624.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: sense body coil 1.5t used with acs nt, intera 1.5t and achieva 1.5t mr system medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its sense body coil 1.5t used with acs nt, intera 1.5t and achieva 1.5t mr system. according to the manufacturer, if users do not follow the instructions for use (ifu) concerning the positioning of the sense body coil 1.5t and its cables in relation to the patient and mr bore, unintended resonances could be created via the patient or elevated coil cable temperature due to rf coupling to the quadrate body coil during an examination. this may result in patient burns. the manufacturer advised users to follow the ifu to position the affected product. according to the local supplier, only the model “achieva 1.5t (system code: 781296; serial numbers: 33532, 33162, 32691, 32680, 32787) is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2015.

Device

SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH