The Recall Desk
HighFDA (Devices)·Z-1776-2025·Announced 2025-05-21

Philips Intera 1.5T MRI quadrature body coil seal adhesive failure recall

Philips recalls certain Intera 1.5T MRI machines due to potential failure of the quadrature body coil seal, which may create sharp edges causing patient injury during scans.

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 recall of a medical device where adhesive failure creates a risk of direct mechanical injury to patients during normal use. No injuries have been reported, placing this in the High (3) severity category per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T Master/Nova MRI system, Model 781106. A total of 103 units were affected—37 in the United States and 66 internationally.

The quadrature body coil (QBC) seal adhesive may fail, creating sharp edges. If the seal becomes loose during the scanning process, these sharp edges may contact patients, potentially causing skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

The recalled product

Product
Intera 1.5T Master/Nova, Model Number: 781106;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI Equipment
Hazard
  • seal-failure
  • sharp-edges
  • laceration
  • tissue-injury
  • hair-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): 781106
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category