Philips Ingenia 1.5T S MRI System Alignment Error Recall
Philips is recalling the Ingenia 1.5T S magnetic resonance imaging (MRI) system due to potential alignment errors in cross reference line functionality when reviewing images generated with the MobiView application.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard described—alignment errors in image review functionality—is a software/display issue with no reported illnesses, injuries, or deaths, making this a moderate precautionary recall.
Plain-English summary
Philips North America LLC is recalling the Ingenia 1.5T S (Model Number 781347) MRI system. The device has a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Two units of the Ingenia 1.5T S were distributed in the United States. The device was also distributed worldwide to Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Côte D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, and the United Arab Emirates.
Affected units have serial numbers 81042 and 81072. The FDA has classified this as a Class II recall. Customers should contact Philips North America LLC for further instructions.
The recalled product
- Product
- Product Name: Ingenia 1.5T S; Model Number: 781347;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- alignment-error
- image-display-error
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 (4)
- Model Number: 781347
- UDI-DI: 00884838068421
- Serial Numbers: 81042
- 81072
Distribution
Distributed nationwide across the United States.
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