SmartPath to dStream for 1.5T, Model Number: 782146;

Recall Insight

This FDA Devices action (record #Z-1782-2025) was formally reported on May 21, 2025, with the manufacturer initiating the action on March 24, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is listed as the recalling firm, operating out of Best. Federal records indicate 3 units OUS units are affected.

The documented reason for this recall is: 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 abr… Distribution data in the federal record shows the product reached: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Cayman Islands, Chile, C…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.