FDA Device recall Z-3237-2026
Ingenia Ambition S and Ingenia Ambition X
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Ingenia Ambition S and Ingenia Ambition X by Philips North America, citing A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3237-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-21 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
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.
Identifiers
| code_info | 1. Model Numbers (REF): 781359(S); UDI-DI: 884838090057; Serial Numbers: 48053, 48126, 48136, 48144, 48020, 48030, 4815…1. Model Numbers (REF): 781359(S); UDI-DI: 884838090057; Serial Numbers: 48053, 48126, 48136, 48144, 48020, 48030, 48155, 48191, 48216, 48218, 48245, 48300, 48183, 48186, 48187, 48222, 48225, 48234, 48240, 48241, 48249, 48269, 48278, 48284, 48288, 48293, 48294, 48299, 48304, 48313, 48317, 48326, 48331, 48051, 48223, 48207, 48028, 48031, 48049, 48050, 48131, 48134, 48242, 48254, 48219, 48000, 48004, 48019, 48032, 48132, 48135, 48145, 48160, 48224, 48244, 48040, 48122, 48039, 48022, 48152, 48012, 48014, 48036, 48037, 48044, 48127, 48151, 48158, 48174, 48184, 48046, 48047, 48055, 48128, 48129, 48153, 48190, 48192, 48194, 48226, 48275, 48181, 48198, 48199, 48200, 48033, 48045, 48001, 48038, 48185, 48238, 48239, 48276, 48010, 48170, 48035, 48172, 48027, 48248, 48146, 48147, 48148, 48163, 48164, 48165, 48169, 48182, 48188, 48271, 48290, 48291, 48297, 48302, 48303, 48308, 48309, 48310, 48321, 48325, 48329, 48337, 48018, 48283, 48177, 48017, 48056, 48250, 48272, 48253, 48268, 48026, 48013, 480 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Philips North America
- Ingenia 3.0T and 3.0T CX
FDA Device · Class II · 2026-10-07 · Philips North America - MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - SmartPath to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade dStream
FDA Device · Class II · 2026-10-07 · Philips North America
All Philips North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3237-2026%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.