Philips Medical Systems Nederland B.V. recalled 3,552 Vue Motion V12 devices worldwide, including the United States. The recall is due to a potential that mis-ordered frames during dynamic cine runs may display out of sequence. Stop using the device and follow the recall instructions provided by the manufacturer.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
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Vue Motion V12 is a cine-imaging device used in radiology for dynamic cardiac and other cine runs. It is distributed worldwide to healthcare facilities.
A mis-ordered frame sequence during cine runs can lead to incorrect image display, potentially impacting diagnostic interpretation.
This recall is not described as part of a broader industry pattern in the provided data.
Clinicians rely on accurate cine frames for diagnosis. Mis-sequenced frames could lead to diagnostic errors or delayed treatment, affecting patient care without a known incident to date.
Recall notices and device labels on the unit; manufacturer recall letter; FDA enforcement page
Refunds or replacements typically take 4-8 weeks after eligibility is confirmed
Document recall notification, device serial numbers, software versions, dates of service, and all communications with the manufacturer
Product: Vue Motion V12 Product Number: 1017979 Manufacturer: Philips Medical Systems Nederland B.V. Quantity: 3,552 units Distribution: Worldwide, including US Software Versions: 12.2.0; 12.2.5; 12.2.8.300; 12.2.8.310; 12.2.8.400; 12.2.8.410; 12.2.8.420; 12.2.8.421; 12.2.8.422; 12.2.8.424; 12.2.5.0; 12.2.5.1; 12.2.5.100; 12.2.5.200; 12.2.5.300; 12.2.5.400; 12.2.5.405; 12.2.5.406. Recall date: 2026-03-05 Status: Active Hazard: Potential mis-ordered frames during dynamic cine runs may display frames out of sequence.
No injuries or incidents have been reported.
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