Ingenia 3.0T and 3.0T CX Recall: Software Issue
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Ingenia 3.0T and 3.0T CX recalled?
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 should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
1. Model number (REF): 1. 781342 (3.0T); UDI-DI: 00884838055339; Serial Numbers: 71001, 71002, 71008, 71031, 71038, 71051, 71061, 71072, 71084, 71088, 71089, 71095, 71101, 71154, 71163, 71164, 71166, 71184, 71185, 71193, 71210, 71231, 71269, 71271, 71288, 71290, 71297, 71301, 71303, 71309, 71311, 71312, 71322, 71335, 71336, 71340, 71341, 71344, 71355, 71375, 71385, 71393, 71412, 71413, 71420, 71422, 71427, 71438, 71441, 71443, 71445, 71446, 71449, 71450, 71459, 71462, 71463, 71475, 71486, 71487, 71489, 71491, 71513, 71521, 71528, 71556, 71558, 71562, 71589, 71604, 71607, 71612, 71615, 71619, 71620, 71639, 71641, 71646, 71665, 71673, 71688, 71697, 71704, 71710, 71715, 71729, 71730, 71739, 71754, 71756, 71757, 71759, 71813, 71817, 71828, 71831, 71841, 71849, 71850, 71853, 71862, 71885, 71896, 71921, 71923, 71954, 71959, 71960, 71962, 71963, 71964, 71986, 71992, 85006, 85020, 85032, 85038, 85046, 85066, 85068, 85076, 85078, 85085, 85087, 85091, 85092, 85102, 85126, 85148, 85150, 85154, 85191, 85201, 85216, 85245, 85279, 85377; 2. Model Number (REF): 781377 (3.0T); UDI-DI: 00884838009813; Serial Numbers: 42012, 42014, 42015, 42017, 42033, 42036, 42048, 42059, 42088, 42092, 42109, 42125, 42126, 42127, 42146, 42169, 42196, 42198, 42206, 42210, 42218, 42220, 42224, 42228, 42234, 42238, 42247, 42258, 42265, 42271, 42282, 42288, 42293, 42305, 42307, 42321, 42322, 42330, 42342, 42352, 42353, 42359, 42360, 42386, 42389, 42396, 42403, 42409, 42412, 42416, 42425; 3. Model Number (REF): 782103 (3.0T); UDI-DI: 00884838098299; Serial Numbers: 85646, 85652, 85679, 85686, 85708, 85723, 85758, 85759, 85762; 4. Model Number (REF): 781271 (3.0T CX); UDI-DI: 00884838068452; Serial Numbers: 78008, 78009, 78011, 78012, 78017, 78018, 78027, 78028, 78033, 78035, 78036, 78039, 78040, 78042, 78045, 78053, 78060, 78062, 78063, 78067, 78068, 78070, 78095, 78100, 78103, 78112, 78113, 78115, 78122, 78145, 78147, 78148, 78155, 78166, 78167, 78186, 78195, 78201, 78202, 78208, 78215, 78217, 78229, 78277, 78286, 78287;
- Agency record number
- Z-3309-2026
- Product
- Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
- Recalling firm
- Philips North America
- Quantity
- 243
- 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.
- Recall started
- August 28, 2026
- Report date
- October 7, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)