Recall Z-1974-2021— Philips Respironics, Inc.

Name: FDA recall Z-1974-2021
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 6 FDA 510(k) clearances: K131882, K131982, K130077 and 3 more. Product: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators 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

6 on FDA's record

K131882 — GEODESICEEG SYSTEM 400 SERIES (GES 400)Electrical Geodesics, Inc.·cleared 2014-02-12
K131982 — REMSTAR AUTO A-FLEX HTRespironics, Inc.·cleared 2013-10-18
K130077 — REMSTAR SERespironics, Inc.·cleared 2013-05-21
K122769 — REMSTAR SERespironics, Inc.·cleared 2012-10-09
K113068 — REMSTAR AUTO A-FLEX HTRespironics, Inc.·cleared 2011-12-16
K091319 — REMSTAR AUTO A-FLEXRespironics Inc., Sleep & Home Respiratory Group·cleared 2009-08-03

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

SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators 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.