Quick Facts at a Glance
- Recall Date
- December 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips North America
- Product type
- MR System
- Model numbers
- MR systems with SW version R11.1 and R12.1. Product Code (REF): 782145. UDI-DI: 00884838108684. Serial Numbers: 17385.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 3, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America or your healthcare provider for instructions. Notification method: Letter
About This Product
The SmartPath to dStream is an MR system used for advanced imaging and diagnostics in medical settings. Healthcare providers purchase these systems for their ability to produce detailed images for evaluating patient conditions.
Why This Is Dangerous
The defect causes potential stiffness value errors in exported MR Elastography maps, which are critical for accurate patient assessments. These inaccuracies can lead to incorrect diagnoses and treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who rely on this specific MR system for patient diagnostics, leading to potential delays in patient care.
Practical Guidance
How to identify if yours is affected
- Locate the product code REF 782145 on your MR system.
- Verify the software version is either R11.1 or R12.1.
- Check the serial number against the recall details. If it matches, your device is affected.
Where to find product info
Product codes and serial numbers are typically located on the back or side of the MR system.
What timeline to expect
Expect a refund or resolution within 4-6 weeks after following the recall instructions.
If the manufacturer is unresponsive
- Document all communications with Philips North America.
- Consider reaching out via multiple contact methods if you receive no response.
- Contact the FDA if the company remains unresponsive.
How to prevent similar issues
- Ensure to check for recalls regularly on medical devices used in your practice.
- Stay updated with the latest software versions and patches.
- Purchase from reputable manufacturers with strong safety records.
Documentation advice
Keep records of all correspondence regarding the recall, including emails and letters, for your reference.
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Product Details
The recalled product is the SmartPath to dStream for 3.0T MR system, with product code REF 782145. The affected software versions are R11.1 and R12.1. This device was distributed in the U.S. and several countries, including Belgium and Canada.
Key Facts
- Recall Date: December 3, 2025
- Reported Date: February 4, 2026
- Hazard Level: High
- Quantity Recalled: 1 unit
- Affected Software Versions: R11.1 and R12.1
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Safety Guide
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