FDA Device recall Z-3315-2026
SmartPath to MR 7700
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of SmartPath to MR 7700 by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3315-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-28 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Philips North America |
| Distribution | US |
Product
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Reason
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 MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Identifiers
| code_info | 1. Model number (REF): 782178; UDI-DI: 00884838122239; Serial Numbers: 42165, 42189, 71081; 2. Model Number (REF): 782…1. Model number (REF): 782178; UDI-DI: 00884838122239; Serial Numbers: 42165, 42189, 71081; 2. Model Number (REF): 782207; UDI-DI: 00884838128576; Serial Numbers: 42055, 42287; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Philips North America
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FDA Device · Class II · 2026-10-07 · Philips North America - MR 7700
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FDA Device · Class II · 2026-10-07 · Philips North America - MR 5300
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All Philips North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3315-2026%22
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