Evolution Upgrade 1 — Class II medical device recall Z-1204-2026
Ongoing recall by Philips North America, reported 2026-02-04, distributed nationwide. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer
| Recall number | Z-1204-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2025-12-03 |
| Classified | 2026-01-29 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, DE, DK, ES, FR, GB, GR, IL, IN, JP, KE, KR, NL, SE, TH, TW |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 00884838099722, 00884838108714 |
| Serial numbers | 70769, 70983, 84741 |
| Model numbers | 00884838099722, 00884838108714, 782116, 782148 |
Product
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1204-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.