Recall Z-0295-2025— Philips Respironics, Inc.
Class I · Ongoing
Class I FDA medical device recall by Philips Respironics, Inc., initiated 2024-10-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.. Reason: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-10-07
- Firm location
- Murrysville, PA, United States
Product description
Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Reason for recall
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Data sourced from openFDA. This site is unofficial and independent of the FDA.