Recall Z-3235-2026
Philips North America Llc · initiated August 21, 2026
Product
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Codes / lots: 1. Model Numbers (REF): 782116 (1.5T); UDI-DI: 884838099722; Serial Numbers: 41130, 70284, 41491, 41196, 41520, 70068, 41024, 41025, 41051, 41139, 41144, 41286, 41327, 41349, 41424, 41432, 41433, 70099, 70202, 81073, 41344, 41229, 41457, 41497, 41413, 41080, 41527, 70205, 70589, 81021, 41179, 41189, 70949; 2. Model Numbers (REF): 782148 (1.5T); UDI-DI: 884838108714; Serial Numbers: 41523, 70630, 70966, 84102, 84473, 84825, 41031, 41043, 41085, 41284, 41392, 41553, 70596, 81006, 70644, 41488, 41534, 70454, 41167, 41375, 41446, 70652, 41011, 70590, 70195, 84628; 3. Model Numbers (REF): 782117 (3.0T); UDI-DI: 884838099739; Serial Numbers: 42246, 85713, 42029, 71774, 85668, 85680, 85685, 85694, 42023, 42024, 42078, 42217, 42402, 71348, 71044, 85698, 85146, 42003, 85663, 85677; 4. Model Numbers (REF): 782143 (3.0T); UDI-DI: N/A; Serial Numbers: 71815, 42440, 71389, 85688, 85690, 85649, 42193, 42366, 85683, 85697, 85701, 85708;
Reason for recall
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
FDA-determined cause: Software design
Action taken
On August 24, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: " To prevent this issue from occurring, o Use the standard 3D Vane scan protocol from the Philips Examcard Database, or o For custom 3D Vane scan protocols, use a maximum of 480 for the reconstruction matrix and use a maximum of 167 for the number of slices. " You may continue to use affected systems in accordance with their intended use. " Circulate this notice to all users or new owners of this device so that they are aware of the issues and associated hazard/harm. " Please retain this Urgent Medical Device letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issue (reference 2026-PD-MR-006).
Details
- Recall number
- Z-3235-2026
- Initiated
- August 21, 2026
- Posted by FDA
- September 18, 2026
- Product code
- LNH – System, Nuclear Magnetic Resonance Imaging
- Quantity
- 91
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El…
- Recalling firm
- Philips North America Llc, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3232-2026 | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3233-2026 | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3234-2026 | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3236-2026 | Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T)…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3237-2026 | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3238-2026 | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T)…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3239-2026 | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2.…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3240-2026 | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3241-2026 | MR 5300 Model Number (REF): 1. 782110, 2. 782152;A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3242-2026 | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |
| Z-3243-2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for…A software issue will terminate an examination during the image reconstruction process if the scan… | 08/21/2026Open, Classified |