Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo

FDA device recall Z-1830-2024 · posted 2024-05-15 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

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

Action taken

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

Root cause

Software design

Status

Open, Classified

Product code

LNH

Quantity affected

19 units

Distribution

Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thaila

Date initiated

2024-04-22

Date posted

2024-05-15

Location

Cambridge, MA

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