The Recall Desk
HighFDA (Devices)·Z-1780-2025·Announced 2025-05-21

Philips Intera 3.0T Quasar Dual MRI Scanner Coil Seal Adhesive Failure

Philips is recalling the Intera 3.0T Quasar Dual MRI scanner (Model 781150) 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: FDA Class II medical device recall where the failure of the QBC seal adhesive creates a risk of patient harm (skin abrasions, lacerations, tissue injury). The source text does not report any illnesses or injuries that have actually occurred, making this a risk-of-harm scenario without reported adverse events, which per the rubric constitutes a High severity rating.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 3.0T Quasar Dual MRI scanner, Model Number 781150. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients during the scanning process.

If the QBC seal becomes loose during scanning, patients are at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

A total of 12 units have been distributed: 5 units in the United States (nationwide distribution) and 7 units internationally across multiple countries including Canada, the United Kingdom, Germany, France, Japan, China, Australia, and others.

Facilities using this scanner should contact Philips for information about inspection and remediation of the affected units.

The recalled product

Product
Intera 3.0T Quasar Dual, Model Number: 781150;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI Scanner / 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): 781150
  • 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 · sharp edges

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