United StatesMultiple Philips MR systems are affected, including Evolution Upgrade 1.5T (REFs 782148, 782116), Evolution Upgrade 3.0T (782143), Ingenia 1.5T (781341, 781396), Ingenia 3.0T (781342, 781377), Ingenia 3.0T CX (781271), Ingenia Ambition S (782108), Ingenia Ambition X (781356, 782109, 782138), Ingenia Elition S (781357, 782106, 782137), Ingenia Elition X (781358, 782107, 782136), MR 7700 (782120, 782153), Upgrade to MR 7700 (782130), SmartPath to dStream for 3.0T (782145) and SmartPath to dStream for XR and 3.0T (781270) when running software version R11.1 or R12.1. They were recalled because exported MR Elastography (MRE) stiffness maps may show incorrect stiffness values when viewed in a Picture Archiving and Communication System (PACS).
What's being recalled
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Recalling firm: Philips North America, Cambridge, MA, United States.
How to identify it
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782148. UDI-DI: 00884838108714. Serial Numbers: 70769, 70983. (2) Product Code (REF): 782116. UDI-DI: 00884838099722. Serial Number: 84741. MR systems with SW version R11.1 and R12.1. Product Code (REF): 782143. UDI-DI: 00884838108660. Serial Numbers: 42225. MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433. (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370. MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781342; UDI-DI: 00884838055339; Serial Numbers: 71607, 85216, 71087, 71619, 71462, 71002, 71885, 71841, 71378, 71269, 85126, 71279, 71088, 71185, 71532, 71344, 71756, 71336, 71459. (2) Product Code (REF): 781377; UDI-DI: 00884838009813; Serial Numbers: 42305, 42299, 42036, 42376, 42321. MR systems with SW version R11.1 and R12.1. Product Code (REF): 781271. UDI-DI: 00884838068452. Serial Numbers: 78017, 78112, 78217, 78123, 78260, 78239. MR systems with SW version R11.1 and R12.1. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669. 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. MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781357; UDI-DI: 00884838088108; Serial Numbers: 46002. (2) Product Code (REF): 782106; UDI-DI: 00884838098329; Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137; UDI-DI: 00884838108615; Serial Numbers: 64034, 64045. MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781358…
The hazard
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)