Events

Safety Alert for Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software

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
    2014-05-08
  • Event Date Posted
    2014-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140508a.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: philips healthcare ingenia, intera, achieva and multiva mr systems using r5.1.1 and r5.1.2 version of software medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its ingenia, intera, achieva and multiva mr systems on r5.1.1 and r5.1.2 with the mobiview software option. according to the manufacturer, the cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing. the cross reference lines are correctly displayed on the unfused stations. the problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. in such situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images. the hazard is only expected in spine examinations, when using a whole spine survey, while the cervical spine is skipped for the clinical scan. there is a risk of misdiagnosis which could lead to incorrect therapy. the risk occurs when cross-reference lines on fused images are relied upon to determine location of transversal images. in mobiview applications other than spine, reference lines are not commonly used to identify or label anatomy because anatomical landmarks are used instead. the manufacturer advises affected users not to perform planning or review planning of transversal images on fused sagittal images which were generated through mobiview post-processing. instead, the planning of transversal scans should only be reviewed on the unfused stations. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2014.

Device

Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Healthcare Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software
  • Manufacturer
    Philips Healthcare

Manufacturer

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