FDA recall Z-1692-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

Vue Motion V12. Product Number: 1017979.

Reason for recall

Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2026-03-05
Report date
2026-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2026