ProductGuru Recalls

Official recall record

Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;

US FDA — Medical Devices · 2026-08-28 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2026-08-28
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
00884838105591
Brand on record
Philips North America

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-23.

More recalls: US FDA — Medical Devices · United States · all filters

Other recalls from this brand

All 58 official recall notices naming Philips North America on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.