Vue Motion cardiac imaging system may display frames out of sequence
The Vue Motion V12 cardiac imaging system may display image frames out of sequence during dynamic cine runs. Philips Medical Systems is recalling 3,552 units worldwide due to this potential defect.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall for a diagnostic imaging system with potential for mis-ordered images that could affect clinical diagnosis. No illnesses or injuries reported in source; hazard is theoretical, placing severity at the 'High' level per rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vue Motion V12 is a cardiac imaging system manufactured by Philips Medical Systems Nederland B.V., Product Number 1017979. The FDA has issued a Class II recall for this device due to a potential defect in which image frames may display out of sequence during dynamic cine runs.
The recall affects 3,552 units with worldwide distribution, including the United States. Affected software versions range from v12.2.0 to v12.2.8.500. The mis-ordering of frames during dynamic cine imaging may cause images to display out of sequence, potentially affecting the diagnostic interpretation of cardiac imaging studies.
Additional information, including specific equipment serial numbers, software version details, and corrective actions, is available from the FDA and Philips Medical Systems.
The recalled product
- Product
- Vue Motion V12. Product Number: 1017979.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Cardiac Imaging
- Hazard
- frame-ordering-error
- diagnostic-imaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Number: 1017979
- (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)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)230301(10)12.2.5.406
- (01)00884838100367(11)230320(10)12.2.5.407
- (01)00884838100367(11)230403(10)12.2.5.408
- (01)00884838100367#(11)231223(10)12.2.8.435
Distribution
Distributed nationwide across the United States.
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