Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Reported: July 21, 2021 Initiated: June 14, 2021 #Z-1956-2021
Product Description
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Reason for Recall
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 255810
- Distribution
- Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.. Recalled by Philips Respironics, Inc.. Units affected: 255810.
Why was this product recalled? ▼
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Critical. Recall number: Z-1956-2021.
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