Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Reported: August 25, 2021 Initiated: July 26, 2021 #Z-2289-2021
Product Description
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
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).
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 18936 (US); 4659 (OUS)
- Distribution
- Worldwide distribution - US nationwide distribution.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B. Recalled by Philips Respironics, Inc.. Units affected: 18936 (US); 4659 (OUS).
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2289-2021.
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