Class II — Philips North America Llc
| Recalling firm | Philips North America Llc |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. |
| Product | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X); |
| Quantity | 965 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cte D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salva… |
| Initiated | 2026-08-21 |
| Classified | 2026-09-18 |
| Recall number | Z-3243-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips North America Llc (Z-3243-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99769/
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