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

Philips Intera 1.0T MRI System Quadrature Body Coil Seal Adhesive Failure

Philips is recalling Intera 1.0T Omni/Stellar MRI systems (37 units: 3 in US, 34 internationally) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that can cause skin injuries 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 an FDA Class II recall for a medical device where injury hazards (skin abrasion, laceration, tissue injury) have been identified and the mechanism of harm is clear, though no reported illnesses or injuries are stated in the source. The source describes a risk-of-harm scenario with direct contact potential, meeting the High severity criterion.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 1.0T Omni/Stellar MRI system, Model Number 781102. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that can come into contact with patients during the scanning process.

If the QBC seal becomes loose during scanning, patients may be at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. A total of 37 units have been distributed: 3 in the United States (nationwide distribution) and 34 internationally across multiple countries.

Patients or healthcare providers who have one of these devices should contact the manufacturer or their authorized distributor for guidance on corrective measures. All serial numbers are affected under Model Number 781102.

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 (MRI)
Hazard

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.

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 · seal adhesive failure

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