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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy EV300

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 Class 2 Device Recall Trilogy EV300see related information
Date Initiated by FirmJuly 26, 2021
Create DateAugust 13, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2289-2021
Recall Event ID 88333
510(K)NumberK181166 
Product Classification Continuous, ventilator, home use - Product Code NOU
ProductTrilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Code Information Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information ContactPhilips Customer Service
800-722-9377
Manufacturer Reason
for Recall		Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
FDA Determined
Cause 2		Labeling design
ActionOn July 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were advised of the two software issues that the firm had identified related to pressure increase. Customers received guidance on how to identify affected products: Devices with software versions devices with software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01 and 1.06.02 are impacted. Customers were provided with actions to take until the upcoming software fix is implemented on your device. Philips will be releasing a software correction to resolve this issue, and will contact customers when the software correction is released. If you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center Trilogy Evo: +1-800-345-6443 Option 2, Option 1 (Available 24/7) Trilogy EV300: +1-800-722-9377 (Available 24/7)
Quantity in Commerce18936 (US); 4659 (OUS)
DistributionWorldwide distribution - US nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NOU
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