Philips Medical Systems Nederland B.v. Veenpluis 4-6 Best Netherlands: System, Image Processing, Radiological

Recall Summary Philips Medical Systems is recalling the Vue Motion V12 image processing system (Product Number 1017979) because image frames may display out of sequence during dynamic cine runs, which are video-like sequences of medical images. This is a Class II recall affecting devices distributed worldwide, including throughout the United States and numerous other countries. The issue could impact the accuracy of medical image interpretation.

Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Product
Vue Motion V12. Product Number: 1017979.
Reason
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-05
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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,...

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b86ed78f-99c6-48cf-a2a4-cbd1bb5e97b3