FDA Device recall Z-3240-2026
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova…
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova… 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-3240-2026 |
| 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
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
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. Intera 1.5T Model Numbers (REF): 781195; UDI-DI: N/A; Serial Numbers: 18774, 18781, 18951, 18958, 18962, 18971, 204…1. Intera 1.5T Model Numbers (REF): 781195; UDI-DI: N/A; Serial Numbers: 18774, 18781, 18951, 18958, 18962, 18971, 20431, 18898, 20429, 18669, 18981, 18982, 18734, 18763, 20427, 18842, 18654, 18878, 18566, 18618, 18752, 20409, 18748, 18743, 18657, 20424, 18755, 18908, 18501, 18646, 18768, 18516, 18554, 18616, 18723, 18725, 18784; 2. Intera 1.5T; Model Numbers (REF): 781295; UDI-DI: N/A; Serial Numbers: 30138, 30297, 30314, 30210, 30137, 30173, 30179, 30104, 30105, 30290, 30208, 30051, 30035, 30143, 30109, 30063, 30237, 30135; 3. Intera 1.5T Achieva IT Nova; Model Numbers (REF): (781175); UDI-DI: N/A; Serial Number: 15003; 4. Intera 1.5T Achieva Nova; Model Numbers (REF): 781172; UDI-DI: N/A; Serial Numbers: 12105, 12049, 12079, 12001, 12086, 12099, 12046, 12057, 12081, 12075, 12078, 12106; 5. Intera 1.5T Achieva Nova-Dual; Model Numbers (REF): 781173; UDI-DI: N/A; Serial Numbers: 13006, 13017, 13058, 13012, 13048, 13049; 6. Intera 1.5T Omni/Stellar; Model Numbers (REF): 781104; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-07 · Philips North America
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3240-2026%22
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