Reported Jul 21, 2021 · Ongoing
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- 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.
- Lot codes and dates
- All Serial Numbers Material Numbers
717 of 717 codes
AC250SAC550SAH250HSAH250SAH260HSAH260SAH260TSAH450HSAH450SAH550HSAH550SAH650HSAH650SAH750HSAH750SAU151HSAU151SAU251HSAU251SAU451HSAU451SAU551HSAU551SAU651HSAU651SAU751HSAU751SCA151HSCA151SCA251HSCA251SCA451HSCA451SCA551HSCA551SCA651HSCA651SCA751HSCA751SCN157HSCN157SCN257HSCN257SCN457HSCN457SCN557HSCN557SCN657HSCN657SCN757HSCN757SDE452HSDE452SDE552HSDE552SDE752HSDE752SDS150HSDS150SDS250HS
- All Serial Numbers Material Numbers
- Amount recalled
- 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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