Food, drugs, devices › Philips North America
Device recall: Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
FDA enforcement event 98111 is a device recall by Philips North America of Cambridge, MA, initiated 3 Dec 2025 and classified Class II, with 13 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips North America has 30 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America, Cambridge, MA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1204-2026 | Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1. | 3 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1205-2026 | Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1. | 1 unit | Class II | Ongoing | 4 Feb 2026 |
| Z-1206-2026 | Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1. | 10 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1207-2026 | Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1. | 24 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1208-2026 | Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1. | 6 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1209-2026 | Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1. | 1 unit | Class II | Ongoing | 4 Feb 2026 |
| Z-1210-2026 | Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1. | 21 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1211-2026 | Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1. | 5 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1212-2026 | Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1. | 31 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1213-2026 | MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1. | 9 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1214-2026 | Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. | 6 units | Class II | Ongoing | 4 Feb 2026 |
| Z-1215-2026 | SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. | 1 unit | Class II | Ongoing | 4 Feb 2026 |
| Z-1216-2026 | SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1. | 3 units | Class II | Ongoing | 4 Feb 2026 |
Context
Other enforcement events for Philips North America
All 30 events for Philips North America
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.