The Recall Desk
HighFDA (Devices)·Z-1781-2025·Announced 2025-05-21

Philips Intera CV MRI Quadrature Body Coil Seal Adhesive Failure Recall

Philips is recalling Intera CV MRI units (Model 781107) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning, including skin abrasions, lacerations, or tissue damage.

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 with a risk-of-harm mechanism (sharp edges, potential for skin abrasion, laceration, and tissue injury). The source text does not report any illnesses or injuries that have actually occurred, making this a theoretical risk scenario that falls under the "High" category per the rubric.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera CV MRI system (Model Number 781107). Six units have been distributed: 4 in the United States nationwide and 2 outside the United States across multiple countries.

The Quadrature Body Coil (QBC) seal adhesive may fail during use, creating sharp edges that can come into contact with patients. If the QBC seal becomes loose during the scanning process, patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

Patients who have undergone or may undergo scans with affected units should consult their healthcare provider or radiology facility if they experience any unexplained injuries. Healthcare facilities operating these devices should inspect the Quadrature Body Coil seal and contact Philips for guidance on repair or replacement.

The recalled product

Product
Intera CV, Model Number: 781107;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI System / Imaging Equipment
Hazard
  • sharp-edges
  • laceration
  • tissue-injury
  • skin-abrasion

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): 781107
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category