# Class II recall Z-3314-2026: Philips North America

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3314-2026 |
| Recalling firm | Philips North America |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for  XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR and 3.0T), 8. 782113 (XR and 3.0T), 9. 782129 (XR and 3.0T), 10. 782118 (Ingenia Elition X), 11. 782144 (Ingenia Elition X), 12. 782163 (Ingenia Elition X);  Software Versions: R11, R12 and R13; |
| Reason | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction. |
| Quantity | 200 |
| Distribution | Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Gree |
| Recall initiated | 2026-08-28 |
| Reported | 2026-10-07 |
| Firm location | Cambridge, MA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3314-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.