Recall Z-1974-2021 ยท BZD Ventilator, Non-Continuous (Respirator)
Philips Respironics, Inc.
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.
| Date | Jul 13, 2021 (initiated Jun 14, 2021) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Urgent Medical Device Recall notification letters were sent to customers beginning on 6/14/21. Immediate Actions to be taken by You, the User: 1. Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. 2. Register your device on the recall website www.philips.com/src-updates Call 1-877-907-7508 if you cannot visit the website or do not have internet access. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. Immediate Actions to be taken by Y |
| Quantity | 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total |
| Distribution | Global distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091319 | REMSTAR AUTO A-FLEX Respironics Inc., Sleep & Home Respiratory Group, Aug 3, 2009 |
| K113068 | REMSTAR AUTO A-FLEX HT Respironics, Inc., Dec 16, 2011 |
| K122769 | REMSTAR SE Respironics, Inc., Oct 9, 2012 |
| K130077 | REMSTAR SE Respironics, Inc., May 21, 2013 |
| K131882 | GEODESICEEG SYSTEM 400 SERIES (GES 400) Electrical Geodesics, Inc., Feb 12, 2014 |
| K131982 | REMSTAR AUTO A-FLEX HT Respironics, Inc., Oct 18, 2013 |