The Recall Desk
HighFDA (Devices)·Z-1772-2025·Announced 2025-05-21

Philips Intera 1.0T MRI Quadrature Coil Seal Adhesive Failure

Philips is recalling certain Intera 1.0T MRI machines due to a Quadrature Body Coil seal adhesive that may fail and create sharp edges. These edges could contact patients during scanning and cause skin abrasions, lacerations, or tissue injury.

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 with risk of sharp edges causing potential lacerations and tissue injury, but no reported illnesses or injuries. Per rubric, risk-of-harm products where injury has not yet been reported score 3.

Plain-English summary

Philips is recalling certain Intera 1.0T Omni/Stellar MRI machines (Model 781102) due to a potential failure of the Quadrature Body Coil (QBC) seal adhesive. The adhesive failure may create sharp edges that could come into contact with patients during scanning procedures.

If the QBC seal becomes loose during a scan, patients may be at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. The company has not reported any confirmed patient injuries to date.

The recall affects 37 units worldwide, including 3 units distributed in the United States and 34 units distributed internationally across more than 80 countries.

Healthcare facilities and clinicians should immediately contact Philips Medical Systems Nederland B.V. for instructions on how to address this issue with affected devices.

The recalled product

Product
Intera 1.0T Omni/Stellar, Model Number: 781102;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Magnetic Resonance Imaging
Hazard
  • sharp-edges
  • laceration
  • skin-abrasion
  • 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): 781102
  • UDI-DI: N/a
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category