FDA Device recall Z-1205-2026
Evolution Upgrade 3.0T. Product Code (REF): 782143
- FDA Device
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Evolution Upgrade 3.0T. Product Code (REF): 782143 by Philips North America, citing the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1205-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-03 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Reason
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Identifiers
| code_info | MR systems with SW version R11.1 and R12.1. Product Code (REF): 782143. UDI-DI: 00884838108660. Serial Numbers: 42225. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1205-2026%22
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