The Recall Desk
HighFDA (Devices)·Z-1777-2025·Announced 2025-05-21

Philips Intera 1.5T MRI machines: Quadrature coil seal failure risk

Philips is recalling 26 Intera 1.5T MRI machines due to potential adhesive failure in the Quadrature Body Coil seal, which may create sharp edges that could cause skin injuries or hair entanglement during patient 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 a Class II medical device recall where no injuries or illnesses have been reported, but the hazard presents a risk of patient harm (skin abrasions, lacerations, hair entanglement, tissue injury) if the QBC seal fails during use, meeting the criteria for a High-severity risk-of-harm product without reported incidents.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T Omni/Stellar MRI system (Model 781104), affecting 26 units distributed worldwide. The Quadrature Body Coil (QBC) seal adhesive may fail during use, creating sharp edges that could contact patients during scanning procedures.

If the seal becomes loose, the resulting sharp edges pose a risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury to patients. The recall includes all serial numbers of the affected model and has been distributed to facilities in the United States and internationally.

Healthcare facilities with the affected Intera 1.5T Omni/Stellar Model 781104 system should contact Philips Medical Systems Nederland B.V. regarding this recall.

The recalled product

Product
Intera 1.5T Omni/Stellar, Model Number: 781104;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI System
Hazard
  • sharp-edges
  • skin-abrasion
  • laceration
  • hair-entanglement
  • tissue-injury

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): 781104
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category