Z-1790-2025Class II
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113
Philips North America LLC / initiated 2025-05-13 / Open, Classified / root cause: software
Philips North America Llc began a recall of Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113 on . FDA classified it as Class II and gives the reason as "Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-1790-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- Reason for recall
- Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Root cause tag
- software
- FDA root cause
- Software design
- Action
- On May 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users You may continue to use your system(s) in accordance with the intended use. A. To avoid the potential issue of an incorrect cross reference line in MobiView generated images, use the same voxel size and field of view across all station scans. B. Do not use cross reference line functionality in box mode, all slices mode, or 3D mode. Use the cross reference line functionality in single slice mode. Circulate this notice to all users of this device so that they are aware of the issues and associated hazard/harm. 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. Please complete and return the attached response form to Philips MR promptly and no later than 30 days from receipt of this letter via email to: [email protected]. Completing this form confirms receipt of the Urgent Medical Device Correction letter, understanding of the issues, and required actions to be taken. 5. Actions planned by Philips MR 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 issues (reference FCO78100566, FCO78100584, FCO78100585, FCO78100620, FCO78100621). If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax. For more information, pl
- Quantity in commerce
- 55 units (2 US, 53 OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
- Product codes and lots
- Model Numbers: (1) 781270, (2) 782113; UDI-DI: (1) 00884838095083, (2) 00884838098909; Serial Numbers: (1) 17283, 17299, 17321, 17356, 17357, 17369, 17378, 17398, 17416, 17425, 17473, 17490, 17499, 17550, 17564, 17565, 17569, 17589, 17590, 17594, 23026, 24012, 24023, 24066, 24075, 24087, 24090, 24110, 34107, 34152, 35043, 35047, 35056, 38004, 38023, 38084, 38089, 38113, 38120, 38199, 38202, 38300, 38366, (2) 17252, 17258, 17346, 24039, 24077, 24146, 34131, 34212, 35071, 38197, 38234, 38291;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1788-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1789-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1790-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1791-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1792-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1793-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1794-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1795-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1796-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1797-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1798-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1799-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1800-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1801-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1802-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1803-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1804-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1805-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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