FDA Device recall Z-1209-2026
Ingenia Ambition S. Product Code (REF): 782108
- FDA Device
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Ingenia Ambition S. Product Code (REF): 782108 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-1209-2026 |
| 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
Ingenia Ambition S. Product Code (REF): 782108. 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): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669. |
|---|
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-1209-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.