FDA-Device2026-04-08Class IIPROCESSING DEFECT
Philips Vue Motion V12 cardiac imaging software recalled for out-of-sequence image frames
OTHERNationwide distribution
Check your Philips Vue Motion V12 software
Philips Vue Motion V12 cardiac imaging software (Product Number 1017979, software versions 12.2.0 through 12.2.8.500) may display image frames out of sequence during dynamic cine runs. This could cause medical staff to review cardiac images in the wrong order, potentially affecting diagnosis.
- If your facility uses Philips Vue Motion V12, contact Philips Medical Systems for a software update or patch
- Review any recent patient studies processed with affected software versions for accuracy
- Check your system's software version against the list of affected versions (12.2.0–12.2.8.500)
Hazard
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Sold states
Worldwide distribution - US Nationwide and the countries of Algeria, Andorra, Angola, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Guernsey, Holy See (Vatican City State), Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Zambia.
Affected count
3,552 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Vue Motion V12. Product Number: 1017979.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2026More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
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