The Recall Desk
HighFDA (Devices)·Z-1773-2025·Announced 2025-05-21

Philips Intera 1.0T MRI scanner coil seal adhesive failure risk

Philips recalls the Intera 1.0T Power/Pulsar MRI scanner. The Quadrature Body Coil seal adhesive may fail during scanning, creating sharp edges that could cause skin abrasions, lacerations, hair entanglement, or tissue injury.

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: The defect presents a risk of harm to patients through sharp edges, with potential for lacerations and tissue injury. However, the source text does not report any actual injuries or illnesses. As a risk-of-harm product without reported injury, this meets the criteria for High severity (score 3).

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Intera 1.0T Power/Pulsar MRI scanner, Model Number 781103. A total of 26 units have been distributed worldwide, including throughout the United States and internationally.

The Quadrature Body Coil (QBC) seal adhesive may fail during use. When this occurs, the loose seal can create sharp edges that may come into contact with patients during the scanning process.

If the QBC seal fails, patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, or tissue injury at the contact point. The defect affects all serial numbers of the recalled model.

Patients who have undergone or are scheduled for MRI scans using an Intera 1.0T Power/Pulsar scanner should consult with their healthcare provider or facility. Healthcare facilities with recalled units should discontinue use and contact Philips Medical Systems Nederland B.V. for instructions on inspection, repair, or replacement.

The recalled product

Product
Intera 1.0T Power/Pulsar, Model Number: 781103;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI Scanner
Hazard
  • sharp-edges
  • skin-abrasion
  • laceration
  • hair-entanglement
  • tissue-injury

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): 781103
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category