FDA recall Z-1973-2021

Philips Respironics, Inc. · Class I · device

Product

DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

Reason for recall

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

Distribution

Global distribution

Key facts

Status
Ongoing
Initiation date
2021-06-14
Report date
2021-07-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1973-2021