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

Philips Intera 1.0T MRI Quadrature Body Coil Seal Failure Recall

Philips is recalling Intera 1.0T Power/Pulsar MRI systems (Model 781103) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and injure patients during scanning.

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 patient harm (skin abrasions, lacerations, tissue injury). The source text does not report any actual illnesses or injuries, only potential hazards; therefore per the rubric, the score is at most 3.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling Intera 1.0T Power/Pulsar MRI systems, Model Number 781103. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that can come into contact with patients.

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. A total of 26 units have been distributed worldwide.

Patients or healthcare providers who operate or maintain these devices should be aware of this risk. Facilities should contact Philips Medical Systems for instructions on inspection, repair, or replacement of affected devices.

The recalled product

Product
Intera 1.0T Power/Pulsar, Model Number: 781103;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI / Imaging Equipment
Hazard
  • sharp-edges
  • laceration
  • abrasion
  • 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): 781103
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category