The Recall Desk
HighFDA (Devices)·Z-1783-2025·Announced 2025-05-21

Philips SmartPath to dStream 3.0T MRI Coil Adhesive Failure Recall

Philips is recalling SmartPath to dStream 3.0T MRI systems (Model 782145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

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: FDA Class II recall involving a medical device with potential for patient injury (skin abrasions, lacerations, tissue damage). The hazard is credible and could cause harm, but no reported illnesses or injuries are stated in the source text, placing this at the High level per the rubric.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling SmartPath to dStream for 3.0T magnetic resonance imaging (MRI) systems, Model Number 782145, distributed nationwide in the US and internationally across numerous countries.

The Quadrature Body Coil (QBC) seal adhesive in these systems may fail during use, creating sharp edges that could come into contact with patients. If the QBC seal becomes loose during the scanning process, patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

Four units were distributed outside the United States. Patients and healthcare providers who use or maintain these systems should contact Philips Medical Systems Nederland B.V. for further guidance on this recall. Healthcare facilities should verify whether they have affected units by checking the Model Number 782145 and serial numbers.

The recalled product

Product
SmartPath to dStream for 3.0T, Model Number: 782145;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI System
Hazard
Affected units
4

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): 782145
  • 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 · adhesive failure

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