Recall Z-1215-2026
Philips North America · initiated December 3, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Codes / lots: MR systems with SW version R11.1 and R12.1. Product Code (REF): 782145. UDI-DI: 00884838108684. Serial Numbers: 17385.
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).
FDA-determined cause: Software design
Action taken
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 representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620).
Details
- Recall number
- Z-1215-2026
- Initiated
- December 3, 2025
- Posted by FDA
- January 29, 2026
- Product code
- LNH – System, Nuclear Magnetic Resonance Imaging
- Quantity
- 1 unit
- 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.
- Recalling firm
- Philips North America, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1204-2026 Class II | Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1205-2026 Class II | Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1206-2026 Class II | Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1207-2026 Class II | Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1208-2026 Class II | Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1209-2026 Class II | Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1210-2026 Class II | Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1211-2026 Class II | Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1212-2026 Class II | Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1213-2026 Class II | MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1214-2026 Class II | Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |
| Z-1216-2026 Class II | SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | 12/03/2025Open, Classified |