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

MRI Coil Seal Failure Creates Risk of Patient Skin Injury

Philips MRI equipment may have a loose Quadrature Body Coil seal that creates sharp edges, risking patient skin lacerations and tissue injury. The seal adhesive can fail during scanning procedures.

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 direct patient contact that poses a risk of physical injury from sharp edges, potentially causing lacerations and tissue injury. Although no illnesses or injuries have been reported in the source, the hazard represents a significant risk-of-harm scenario consistent with the rubric criteria for High severity.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the SmartPath to dStream for 1.5T MRI equipment (Model 782146) due to a defect in the Quadrature Body Coil (QBC) seal. The adhesive securing the seal may fail during normal use.

If the QBC seal becomes loose during a scanning procedure, sharp edges may form and come into contact with patients. This poses risks including skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

Three units of this equipment were distributed outside the United States to healthcare facilities across numerous countries worldwide, including locations in North America, Europe, Asia, Africa, and other regions.

The recalled product

Product
SmartPath to dStream for 1.5T, Model Number: 782146;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI / Diagnostic Imaging
Hazard
  • sharp-edges
  • laceration
  • skin-abrasion
  • tissue-injury
  • entanglement

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.

Related recalls

Same category