Philips Ingenia 3.0T MR Systems May Not Warn of Low Ventilation Settings
Philips Ingenia 3.0T MR systems with software R5.7.1 may fail to warn about low ventilation, potentially causing patient overheating or burning sensations. 19 units affected worldwide.
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: FDA Class II recall involving potential patient thermal injury (overheating or burning sensation) due to a software defect that prevents warning of dangerous ventilation settings. No reported injuries or illnesses are mentioned in the source, placing this at High for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling Ingenia 3.0T with Evolution Upgrade 3.0T magnetic resonance (MR) imaging systems. These are diagnostic medical devices classified as FDA Class II recall (Z-1830-2024).
The systems running software version R5.7.1 contain a defect where the software may not issue a warning when ventilation is set to a low level. This malfunction could result in increased patient body temperature or burning sensations during imaging procedures.
A total of 19 units are affected. The systems are distributed in five U.S. states (California, Kansas, Mississippi, New Hampshire) and internationally in Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, and the United Kingdom.
Healthcare facilities operating these systems should verify their software version and equipment serial numbers against the recall information and contact Philips for corrective action. Operators should exercise caution with ventilation settings until the software issue is resolved.
The recalled product
- Product
- Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
- Manufacturer
- Philips North America Llc
- Affected units
- 19
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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