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U.S. Department of Health and Human Services

Class 2 Device Recall Vue Motion V12

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 Class 2 Device Recall Vue Motion V12see related information
Date Initiated by FirmMarch 05, 2026
Date PostedMarch 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1692-2026
Recall Event ID 98520
510(K)NumberK151774 
Product Classification System, image processing, radiological - Product Code LLZ
ProductVue Motion V12. Product Number: 1017979.
Code Information Product Number: 1017979, Software Version: v12.2.0 - v12.2.8.500. UDI Numbers: (01)00884838100367(11)200221(10)12.2.5, (01)00884838100367(11)230223(10)12.2.8.300, (01)00884838100343(11)200423(10)12.2.5.0, (01)00884838100367(11)230615(10)12.2.8.310, (01)00884838100367(11)200903(10)12.2.5.1, (01)00884838100367(11)230720(10)12.2.8.400, (01)00884838100343(11)201125(10)12.2.5.100, (01)00884838100367(11)230921(10)12.2.8.410, (01)00884838100343(11)210217(10)12.2.5.200, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)210628(10)12.2.5.300, (01)00884838100350(11)240116(10)12.2.8.421, (01)00884838100367(11)210628(10)12.2.5.300, (01)00884838100350(11)240204(10)12.2.8.422, (01)00884838100343(11)220525(10)12.2.5.400, (01)00884838100350(11)240226(10)12.2.8.424, (01)00884838100367(11)230223(10)12.2.5.405, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100336(11)230301(10)12.2.5.406, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)230320(10)12.2.5.407, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)230403(10)12.2.5.408, (01)00884838100367#(11)231223(10)12.2.8.435, (01)00884838100343(11)240211(10)12.2.5.413,(01)00884838100367#(11)231228(10)12.2.8.435A, (01)00884838100343(11)20240923(10)12.2.5.414, (01)00884838100343(11)240917(10)12.2.8.436, (01)00884838100343(11)250728(10)12.2.5.416, (01)00884838100367(11)241014(10)12.2.8.437, (01)00884838100367(11)210308(10)12.2.8.0, (01)00884838100343(11)241128(10)12.2.8.438, (01)00884838100367(11)220127(10)12.2.8.100, (01)00884838100367(11)250122(10)12.2.8.439, (01)00884838100343(11)220417(10)12.2.8.130, (01)00884838100350(11)240407(10)12.2.8.440, (01)00884838100350(11)221213(10)12.2.8.200, (01)00884838100367(11)210308(10)12.2.8.0, (01)00884838100350(11)230301(10)12.2.8.210, (01)00884838100367(11)240616(10)12.2.8.500. 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FEI Number 3002807880
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
For Additional Information ContactInformatics Customer Support
877-3282808 Ext. 4
Manufacturer Reason
for Recall		Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
FDA Determined
Cause 2		Software design
ActionPhilips 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).
Quantity in Commerce3,552 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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