Philips North America recalls SmartPath to dStream for 3.0T. Product Code (REF): 782145.
Recalled Product
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Hazard / Issue
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: MR systems with SW version R11.1 and R12.1. Product Code (REF): 782145. UDI-DI: 00884838108684. Serial Numbers: 17385.
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