Home › Philips Medical Systems Nederland B.V. › Achieva/Intera
Achieva/Intera
Philips Medical Systems Nederland B.V. · Model Upgrades Achieva/Intera to R5.7 · UDI-DI 00884838101142
10
510(k) clearances
4,751
Adverse events (37 deaths)
723
Recalls
146
Facilities
Description
R5.7 brings software and application improvements. These include SmartExam enhancements with Quick Smart Survey. Other SW enhancements are including Prescan Redesign, Automated Analysis Software to generate data for American College of Radiology (ACR) Accreditation etc. R5.7 is also enabler for optional new clinical features like 4D FreeBreathing, MR Elastography Extension, MultiBand SENSE with dS Head coil and in 1.5T & Diffusion Excellence Pack.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
| 2026-08-28 | Philips North America | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.