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

Recall number

Z-3316-2026

Recalling firm

Philips North America

Product

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

Status

Open, Classified

Initiated

2026-08-28

Posted

2026-09-25

Terminated

not on file

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.

Root cause

Software design

Action

On August 28, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. To prevent the issue from occurring while Philips is developing the software solution, use the Classic DICOM transfer option for exporting DTI scans. 2. You may continue to use your system(s) in accordance with the intended use. 3. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. 4. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed.

Quantity

1

Distribution

Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.

Lot, serial or model codes

Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;

510(k) numbers

["K213516"]

PMA numbers

not on file

Product code

LNH

Firm FEI

3006648320

Firm city

Cambridge

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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