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

Philips MRI Machine Coil Seal May Develop Sharp Edges

Philips SmartPath MRI equipment may develop a failing coil seal that creates sharp edges, potentially causing skin injuries and lacerations to 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: This is an FDA Class II recall involving a medical device with risk of patient harm (skin abrasions, lacerations, tissue injury). No injuries or illnesses have been reported in the source text, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems has issued a recall of the SmartPath to dStream for 3.0T MRI machine (Model 782145) due to a potential failure of the Quadrature Body Coil (QBC) seal adhesive.

The seal adhesive 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 face potential risks including skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

The recall affects 4 units distributed internationally, including throughout the United States and numerous countries. Philips recommends that healthcare facilities using affected equipment review the specific model number (782145) and contact the manufacturer for guidance on inspection and remediation.

No patient injuries have been reported at this time. Facilities should discontinue use of affected units or take appropriate preventive measures to avoid patient contact with the seal area until remediation can be completed.

The recalled product

Product
SmartPath to dStream for 3.0T, Model Number: 782145;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Magnetic Resonance Imaging (MRI)
Hazard
  • sharp-edges
  • skin-abrasion
  • laceration
  • tissue-injury
  • hair-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): 782145
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category