The Recall Desk
HighFDA (Devices)·Z-1829-2024·Announced 2024-05-22

MRI System Software May Fail to Warn of Inadequate Ventilation

Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.

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 Class II recall involving a medical device with potential risk of thermal injury from software warning system failure. No illnesses or injuries have been reported, and the hazard remains theoretical, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Philips has recalled 32 Ingenia 1.5T with Evolution Upgrade MRI systems due to a software issue. The systems with software version R5.7.1 may not provide proper warning alerts when ventilation settings are inadequate.

Without proper warning of low ventilation conditions, patients undergoing MRI examination may experience elevated body temperature or burning sensations. The recall affects 32 identified units with specific serial numbers.

The affected systems are distributed across California, Kansas, Mississippi, and New Hampshire in the United States, and internationally in Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, and the United Kingdom.

The recalled product

Product
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
  • thermal-injury
  • software-defect

Distribution

Distributed nationwide across the United States.

Related recalls

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