FDA Device recall Z-3238-2026
Ingenia 3.0T and Ingenia 3.0T CX
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Ingenia 3.0T and Ingenia 3.0T CX 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-3238-2026 |
| 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 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
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): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 7…1. Model Numbers (REF): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 71328, 71342, 71419, 71550, 71551, 71555, 71557, 71674, 71693, 71949, 85036, 85155, 71266, 71345, 71392, 71395, 71628, 85393, 71216, 71651, 85208, 71163, 71408, 71499, 71541, 71668, 71771, 71602, 71260, 71276, 71324, 71726, 71068, 71300, 71482, 71339, 71452, 71464, 71465, 71468, 71470, 71471, 71472, 71473, 71479, 71480, 71492, 71497, 71506, 71509, 71511, 71514, 71516, 71517, 71519, 71520, 71548, 71553, 71554, 71559, 71560, 71567, 71588, 71596, 71601, 71605, 71609, 71614, 71621, 71622, 71624, 71626, 71629, 71631, 71633, 71637, 71642, 71653, 71654, 71685, 71687, 71690, 71692, 71695, 71698, 71699, 71702, 71707, 71708, 71709, 71713, 71714, 71716, 71734, 71738, 71744, 71755, 71765, 71775, 71779, 71783, 71784, 71786, 71788, 71804, 71807, 71814, 71818, 71819, 71820, 71821, 71834, 71839, 71840, 71856, 71861, 71868, 71872, 71875, 71876, 71877, 71894, 71898, 71908, 71913, 71917, |
|---|
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-3238-2026%22
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