The Recall Desk
HighFDA (Devices)·Z-1782-2025·Announced 2025-05-21

Philips SmartPath dStream 1.5T MRI coil may create sharp edges

Philips is recalling SmartPath to dStream 1.5T MRI units (Model 782146) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, lacerations, or tissue injury to patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device with risk of patient injury (skin abrasions, lacerations, tissue injury) from a mechanical failure. No reported illnesses or injuries are mentioned in the source, but the hazard is real and facility-based, placing it at High per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling SmartPath to dStream for 1.5T MRI systems, Model Number 782146 (all serial numbers). The Quadrature Body Coil (QBC) seal adhesive may fail during use, creating sharp edges that could come into contact with patients during scanning.

If the QBC seal becomes loose during the scanning process, patients may be at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. Three units have been distributed outside the US across numerous countries worldwide, and affected devices are in use across the United States.

Patients or healthcare facility personnel who believe they have been exposed to a loose or damaged QBC seal should contact their device manufacturer or healthcare provider for guidance on inspection and potential remediation of affected units.

The recalled product

Product
SmartPath to dStream for 1.5T, Model Number: 782146;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI System / Quadrature Body Coil
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Number (REF): 782146
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · sharp edges

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