FDA Device recall Z-3239-2026
Ingenia Elition S and Ingenia Elition X
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Ingenia Elition S and Ingenia Elition 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-3239-2026 |
| 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 Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(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): 781357(S); UDI-DI: 884838088108; Serial Numbers: 46083, 46045, 46095, 46119, 46121, 46024, 4604…1. Model Numbers (REF): 781357(S); UDI-DI: 884838088108; Serial Numbers: 46083, 46045, 46095, 46119, 46121, 46024, 46044, 46055, 46061, 46052, 46001, 46005, 46011, 46048, 46057, 46060, 46066, 46078, 46081, 46016, 46026, 46032, 46033, 46037, 46046, 46054, 46058, 46059, 46068, 46069, 46075, 46082, 46003, 46019, 46111, 46007, 46107, 46067, 46093, 46030, 46031, 46049, 46050, 46089, 46014, 46065, 46071, 46077, 46088, 46109; 2. Model Numbers (REF): 782106(S); UDI-DI: 884838098329; Serial Numbers: 46247, 46250, 46316, 46376, 46200, 46368, 46324, 46331, 46338, 46363, 46367, 46383, 46394, 46398, 46399, 46400, 46201, 46202, 46220, 46225, 46352, 46310, 46234, 46205, 46207, 46209, 46211, 46214, 46215, 46226, 46228, 46235, 46237, 46239, 46240, 46241, 46282, 46281, 46297, 46304, 46317, 46354, 46212, 61010, 46206, 46362, 46393, 46348, 46217, 46289, 46233, 46353, 46213, 46218, 46222, 46384, 46224, 46265, 46286, 46390, 46263, 46307, 46387, 46403; 3. Model Numbers (REF): 782137(S); UDI-DI: 88483810861 |
|---|
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-3239-2026%22
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