Z-1972-2021 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- June 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
Product Description
Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 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 Pattern
Global distribution
Code Information
All Serial Numbers Material Numbers: DSX9999H11 INX9999H19 RINX9999H19