Recall Z-1973-2021— Philips Respironics, Inc.

Name: FDA recall Z-1973-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-14

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2021-06-14. It names 5 FDA 510(k) clearances: K113053, K111378, K102465 and 2 more. 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: 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..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2021-06-14
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

5 on FDA's record

K113053 — BIPAP A 30 VENTILATORY SUPPORT SYSTEMRespironics, Inc.·cleared 2012-02-01
K111378 — OXIMETRY INTERFACE KITPhilips Respironics, Inc.·cleared 2011-10-04
K102465 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEMRespironics, Inc.·cleared 2011-03-24
K092818 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEMRespironics, Inc.·cleared 2010-01-22
K090248 — BIPAP AUTOSVRespironics Inc., Sleep & Home Respiratory Group·cleared 2009-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.