The Recall Desk
HighFDA (Devices)·Z-1779-2025·Announced 2025-05-21

Philips Intera 1.5T R11 MRI System Quadrature Body Coil Seal Adhesive Failure

Philips is recalling Intera 1.5T R11 MRI systems because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could contact patients and cause skin injuries.

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 for a medical device with a risk of patient injury from sharp edges (skin abrasions, lacerations, tissue injury). The source text does not report any actual illnesses or injuries to date, making this a risk-of-harm product where injury has not yet been reported, which per the rubric merits a High (3) severity.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T R11 MRI system (Model Number 781170) due to a failure in the Quadrature Body Coil (QBC) seal adhesive. The adhesive may fail and create sharp edges that may come into contact with patients during imaging.

If the QBC seal becomes loose during the scanning process, patients may be at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury from the sharp edges.

A total of 23 units have been distributed: 10 in the United States (nationwide) and 13 internationally across numerous countries. Patients who have undergone or are scheduled for MRI procedures on affected systems should consult their healthcare provider or facility about the potential risk.

Healthcare facilities with affected units should contact Philips Medical Systems Nederland B.V. regarding the issue and any remediation steps.

The recalled product

Product
Intera 1.5T R11, Model Number: 781170;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Diagnostic Imaging / MRI System
Hazard
  • sharp-edges
  • laceration-risk
  • skin-abrasion-risk
  • tissue-injury-risk

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): 781170
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category