Philips North America SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Brand
Philips North America
Lot Codes / Batch Numbers
a. Model No. 781270, UDI-DI 00884838095083. b. Model No. 782113, UDI-DI 00884838098909. c. Model No. 782129, UDI-DI 00884838105805. All units affected
Products Sold
a. Model No. 781270; UDI-DI 00884838095083. b. Model No. 782113; UDI-DI 00884838098909. c. Model No. 782129; UDI-DI 00884838105805. All units affected
Philips North America is recalling SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129. due to The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose duri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Recommended Action
Per FDA guidance
On January 4, 2024, the firm began notification of affected customers via URGENT Medical Device Correction letters. Customers were provided with precautions to take when using the device, including inspection of the QBC seal for separation. If the QBC seal is found to be loose, or becomes loose during a patient scan, customers should immediately stop use and contact their local Philips service representative. Customers should also ensure that all users of the device are aware of the issue and retain the letter with affected systems until a solution is installed. Philips will contact customers to schedule a time for a Field Service Engineer (FSE) to visit your site and replace your system's QBC Seal. Philips plans to start implementing corrections in Q3 2024. 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). Revision B of the URGENT Medical Device Correction letter was distributed to the additional US consignees on 24-Mar-2025. It was later identified that UMDC Rev B contained three MR systems with a 70cm bore (Ingenia 1.5T: 781341, Ingenia 3.0T: 781377, Ingenia Ambition X: 782109) which were incorrectly included, as the scope of this field action is MR systems with 60cm bore. The URGENT Medical Device Correction letter was updated to Rev C to remove these systems. Revision C of the UMDC was distributed to the additional US consignees on 09-Apr-2025.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
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