The Recall Desk
HighFDA (Devices)·Z-1778-2025·Announced 2025-05-21

Philips Intera 1.5T MRI Scanner QBC Seal Adhesive Failure Risk

Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating 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: The source is FDA Class II. The hazard involves potential for injury (skin abrasions, bruises, lacerations, tissue injury) from a medical device failure, and the source text does not report any illnesses or injuries yet. This meets the rubric criterion for High: "risk-of-harm products where injury has not yet been reported."

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T Power/Pulsar MRI scanner (Model Number 781105) due to a potential failure of the Quadrature Body Coil (QBC) seal adhesive. The adhesive failure may create sharp edges that could come in 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. The recall affects 121 units worldwide, including 51 units distributed in the United States and 70 units distributed internationally across multiple countries.

Facilities using the Intera 1.5T Power/Pulsar with Model Number 781105 should contact Philips Medical Systems for further instructions regarding this recall.

The recalled product

Product
Intera 1.5T Power/Pulsar, Model Number: 781105;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI Scanner
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): 781105
  • 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 failure

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