The Recall Desk
HighFDA (Devices)·Z-1771-2025·Announced 2025-05-21

Philips Intera 0.5T Standard MRI System Quadrature Body Coil Seal

Philips is recalling the Intera 0.5T Standard MRI system (Model 781101) because the Quadrature Body Coil seal adhesive may fail and create sharp edges that could injure 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: FDA Class II recall involving a medical device where patient injury risk is explicitly documented (skin abrasions, lacerations, tissue injury). The source text describes potential harms without reporting that illnesses or injuries have already occurred, placing this at the High level per the rubric.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 0.5T Standard MRI system, Model Number 781101. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may contact patients during the scanning process.

If the QBC seal becomes loose during scanning, patients face risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. A total of 14 units have been distributed worldwide, including nationwide distribution in the United States and international distribution across multiple countries.

Patients or healthcare providers who have concerns about this product should contact Philips Medical Systems Nederland B.V. for guidance on inspection, repair, or replacement options.

The recalled product

Product
Intera 0.5T Standard, Model Number: 781101;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI System / Diagnostic Imaging
Hazard
Affected units
14

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): 781101
  • 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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