The Recall Desk
HighFDA (Devices)·Z-0954-2024·Announced 2024-02-07

MRI Machine Coil Seal Adhesive May Create Sharp Edges

The Intera Achieva 1.5T Pulsar MRI machine's Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. All units of this model are affected.

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 a risk-of-harm product where injury has not yet been reported. The adhesive failure creates a clear hazard of skin and tissue injury through contact with sharp edges, meeting the criteria for a High severity rating despite the absence of documented incidents.

Plain-English summary

Philips North America is recalling the Intera Achieva 1.5T Pulsar MRI machine (Model 781171) due to a potential defect in the Quadrature Body Coil seal adhesive.

The seal adhesive may fail during the scanning process, creating sharp edges on the coil. If these sharp edges come into contact with patients during scanning, they pose a risk of injury including skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

All units of this model are affected. Healthcare facilities should take appropriate precautions. For guidance on device inspection or servicing, contact Philips North America or the FDA.

The recalled product

Product
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
Manufacturer
Philips North America
Category
Medical Device — MRI Machine
Hazard
  • adhesive-failure
  • sharp-edge
  • laceration
  • abrasion
  • 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 (2)

  • Model No. 781171
  • UDI-DI N/A. All units affected

Distribution

Distributed nationwide across the United States.

Related recalls

Same category