|
Class 2 Device Recall Philips Ingenia 1.5T with Evolution Upgrade 1.5T and Ingenia 3.0T with Evolution Upgrade 3.0T |
|
Date Initiated by Firm |
April 22, 2024 |
Date Posted |
May 15, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1829-2024 |
Recall Event ID |
94493 |
510(K)Number |
K193215
|
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
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 |
Code Information |
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
|
Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
|
For Additional Information Contact |
Customer Care Solution Center 800-722-9377
|
Manufacturer 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
|
FDA Determined Cause 2 |
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.
|
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland BV
|
|
|
|