Z-1829-2024Class II

Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems...

Name: Z-1829-2024 Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems...
Creator: Philips North America Llc
Published: 2024-04-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-04-22 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of 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 on 2024-04-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1829-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-22
Posted: 2024-05-15
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
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1829-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1829-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-15
Z-1830-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-15

Product code LNH

K193215Class IIAchieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. / cleared 2020-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)