Philips North America Llc: 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

Recall number

Z-1829-2024

Recalling firm

Philips North America Llc

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

Status

Open, Classified

Initiated

2024-04-22

Posted

2024-05-15

Terminated

not on file

Reason

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

Software design

Action

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

Quantity

32 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, Thailand, United Kingdom.

Lot, serial or model codes

UDI-DI: (01)00884838099722(21) Serial Numbers: 41017 41024 41025 41041 41047 41051 41080 41089 41130 41143 41144 41189 41196 41226 41235 41286 41287 41344 41367 41413 41432 41433 41497 41520 70093 70099 70202 70260 70589 70996 81073 84370

510(k) numbers

["K193215"]

PMA numbers

not on file

Product code

LNH

Firm FEI

3016618143

Firm city

Cambridge

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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