Recall Z-1692-2026 ยท LLZ System, Image Processing, Radiological
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Vue Motion V12. Product Number: 1017979.
| Date | Mar 27, 2026 (initiated Mar 5, 2026) |
| Status | Open, Classified |
| Reason | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. |
| Root cause | Software design |
| Action | Philips Medical notified consignees on about 03/02/2026 via URGENT Medical Device Correction letter. Consignees were instructed to first identify, and how to identify, if the affected products are on hand. If so, they were further instructed that if they do NOT have thumbnail enabled, they will NOT experience this issue described, but if they HAVE thumbnail enabled, when reviewing multi frame studies, always review the frame number displayed on the screen as the correct frame number is visible on the screen. Consignees were told that they may continue to use your system(s) in accordance with |
| Quantity | 3,552 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151774 | CARESTREAM Vue Motion Carestream Health, Inc., Sep 21, 2015 |