The Recall Desk
HighFDA (Devices)·Z-1770-2025·Announced 2025-05-21

Philips Enterprise 1.5T MRI Systems Recalled for Potentially Sharp Coil Seal

Philips recalls certain Enterprise 1.5T MRI systems (Model 781145) due to potential adhesive failure in the Quadrature Body Coil seal that may create sharp edges. These edges could contact patients during scanning 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 recall involves a medical device with a documented failure mechanism (adhesive seal degradation) that creates a risk of patient injury including abrasions, lacerations, and tissue damage. While classified as FDA Class II and with no reported illnesses mentioned in the source, it meets the criterion of a 'risk-of-harm product where injury has not yet been reported.'

Plain-English summary

This recall affects Philips Enterprise 1.5T MRI systems (Model 781145). A total of 34 units have been identified: 32 in the United States and 2 distributed internationally.

The Quadrature Body Coil (QBC) is a component of the MRI system that uses an adhesive seal. This adhesive may fail during normal operation, creating sharp edges on the coil. If the seal becomes loose during the scanning process, these sharp edges may come into contact with patients.

Patient contact with the sharp edges could result in skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. The specific risk depends on where contact occurs and the degree of seal failure.

Patients scheduled for MRI scans should consult with their healthcare provider or the facility where the scan will be performed. Healthcare facilities with this MRI model should verify their device status and contact Philips Medical Systems Nederland B.V. for information about inspection, repair, or replacement options.

The recalled product

Product
Enterprise 1.5T, Model Number: 781145;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI / Imaging Equipment
Hazard
  • sharp-edges
  • skin-abrasion
  • laceration
  • 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): 781145
  • UDI-DI: N/A
  • All serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category