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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia

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 Class 2 Device Recall Ingeniasee related information
Date Initiated by FirmAugust 28, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3316-2026
Recall Event ID 99834
510(K)NumberK213516 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductUpgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Code Information Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;
FEI Number 3006648320
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionOn 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 in Commerce1
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LNH
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