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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 32
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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