PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls 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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Vue Motion V12. Product Number:1017979UDI Numbers
What the firm is doing
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 the intended use and by provided the recommendation in the letter, to circulate the letter to all users of this device so that they are aware of the potential issue retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Consignees were also requested to complete and return the provided response form. A Philips representative will contact each consignee to schedule a time to install a software solution on the affected system(s) to resolve the issue (reference C&R 2025-EI-RI-003).
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1692-2026
- FDA 510(k) clearance · K151774The device's official FDA premarket clearance record
- FDA device classification · LLZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.2050The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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