FDAClass IJuly 21, 2021

Philips Respironics E30 with Humidifier recall

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19…

Why was Philips Respironics E30 with Humidifier recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Serial Numbers Material Numbers: DSX9999H11 INX9999H19 RINX9999H19

Product
Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19…
Recalling firm
Philips Respironics, Inc.
Quantity
15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
Distribution
Global distribution
Recall date
July 21, 2021
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls