Philips North America Llc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: (01)00884838099739(21) Serial Numbers: 42029 42217 42246 71044 71774 85146 85645 85663 85664 85668 85677 85680 85681 85685 85700 85704 85705 85706 85713
Philips North America Llc is recalling Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical due to Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Recommended Action
Per FDA guidance
Philips issued URGENT Medical Device Correction letter on 4/22/24 via FedEx. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: a. Customers can continue to use the identified system(s) in accordance with the intended use pertaining to setting patient ventilation. (Reference IFU, including below information). {If your Ingenia 1.5T or Ingenia 3.0T system(s) has been upgraded to Ingenia Evolution configuration and running R5.7 software, it is impacted by this issue. (Note: customer will not see SW version detail of R5.7.1). o As stated in both IFU sections Adjust Ventilation in Bore and Adjusting the Bore Ventilation, The MR system has a recommended ventilation level. This is a static level based on average scans and system specific conditions. The system does not change the recommended ventilation level for e.g. high SAR scans, examination room temperature and patient weights, clothing and conditions. It is the responsibility of the operator to determine the level of ventilation for different scans and conditions together with the patient. Note: The recommended level is identified as level 3 in the IFU and in the images shown in Figure 1. o When setting ventilation at the VitalScreen, (IFU section Adjusting the Bore Ventilation) and ventilation is set to a value marked with a caution sign, you are warned that the patient might get too warm and that you need to pay attention. o When setting ventilation at the Operator Console (IFU Section Adjusting Ventilation in Bore): Current patient ventilation level, Level 3 is recommended. Use the <=> and <-> buttons above to modify the patient ventilation level. o Note: Should Patient Ventilation level be below level 3, operator is to pay additional attention to patient temperature. b. Refer to Appendix A for specific details regarding the software issue descriptions and advice to customers. c. Please co
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View official FDA recall noticePage updated: Jan 10, 2026
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