Recall Z-1206-2026 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
| Date | Jan 29, 2026 (initiated Dec 3, 2025) |
| Status | Open, Classified |
| Reason | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). |
| Root cause | Software design |
| Action | Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips represe |
| Quantity | 10 units |
| 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, Unite |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Apr 10, 2020 |