—#207311

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

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193215
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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, Thailand, United Kingdom.

Timeline

Recall initiated: 2024-04-22
Posted by FDA: 2024-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207311. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.