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

Philips Intera MRI Scanner Coil Seal Adhesive Failure Risk

The Philips Intera 3.0T Quasar Dual MRI scanner may have a failing quadrature body coil seal adhesive that creates sharp edges, posing risk of skin injuries including lacerations and tissue damage to patients.

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 medical device recall involving risk-of-harm through sharp edges that could cause serious injuries such as lacerations and tissue damage. However, the source text does not report any illnesses or injuries to date, making this a theoretical risk scenario that meets the rubric criteria for Score 3.

Plain-English summary

The Philips Intera 3.0T Quasar Dual MRI scanner (Model 781150) is being recalled. The quadrature body coil (QBC) seal adhesive may fail, creating sharp edges that could come into contact with patients.

When the QBC seal becomes loose during scanning, the sharp edges may cause various injuries including skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

The recall affects 12 units of this MRI model: 5 in the United States with nationwide distribution, and 7 units internationally distributed across more than 80 countries.

The recalled product

Product
Intera 3.0T Quasar Dual, Model Number: 781150;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Diagnostic Imaging / MRI Equipment
Hazard
  • sharp-edges
  • abrasion
  • laceration
  • tissue-injury
  • entanglement

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.

Related recalls

Same category