Philips North America: Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

Hazard

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Details from the source

Reason for recall: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom. Quantity: 21 units Lot/code info: MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356; UDI-DI: 00884838090040; Serial Numbers: 47206, 47038, 47068, 47260, 47294, 47029, 47189. (2) Product Code (REF): 782109; UDI-DI: 00884838098350; Serial Numbers: 47849, 47634, 47534, 47726, 47760, 47706, 47789, 47642, 47681, 47761, 47771, 47767, 47862. (3) Product Code (REF): 782138; UDI-DI: 00884838108622; Serial Numbers: 49057.

UPC codes

00884838090040, 00884838098350, 00884838108622

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.