The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1777-2025·Announced 2025-05-21

Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Failure

Philips is recalling the Intera 1.5T Omni/Stellar MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and cause patient injury. The loose seal during scanning could result in skin abrasions, bruises, lacerations, hair loss, or tissue damage.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The source text describes a risk-of-harm product where the hazard is physical injury (skin abrasions, lacerations, tissue damage) with no reported illnesses or injuries documented. Under the rubric, a risk-of-harm scenario without reported injury scores as High (3), and FDA Class II recalls are typically 3 or higher. The physical injury potential and medical device classification support a High rating.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T Omni/Stellar MRI scanner (Model Number 781104). The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that could come into contact with patients during the scanning process.

If the QBC seal becomes loose during scanning, patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. A total of 26 units have been distributed—7 in the United States on a nationwide basis and 19 internationally across multiple countries.

Healthcare facilities operating affected units should assess their machines for seal integrity and contact Philips Medical Systems for guidance on inspection and remediation options to prevent patient exposure to the potential hazard.

The recalled product

Product
Intera 1.5T Omni/Stellar, Model Number: 781104;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Diagnostic Imaging Equipment
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): 781104
  • 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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