FDA Device recall Z-1974-2021
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironic…
- FDA Device
- Class I
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class I recall of SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironic… by Philips Respironics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1974-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-06-14 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | n/a |
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.
Identifiers
| code_info | All Serial Numbers Material Numbers: AC250S AC550S AH250HS AH250S AH260HS AH260S AH260TS AH450HS AH450S AH5…All Serial Numbers Material Numbers: AC250S AC550S AH250HS AH250S AH260HS AH260S AH260TS AH450HS AH450S AH550HS AH550S AH650HS AH650S AH750HS AH750S AU151HS AU151S AU251HS AU251S AU451HS AU451S AU551HS AU551S AU651HS AU651S AU751HS AU751S CA151HS CA151S CA251HS CA251S CA451HS CA451S CA551HS CA551S CA651HS CA651S CA751HS CA751S CN157HS CN157S CN257HS CN257S CN457HS CN457S CN557HS CN557S CN657HS CN657S CN757HS CN757S DE452HS DE452S DE552HS DE552S DE752HS DE752S DS150HS DS150S DS250HS DS250S DS450HS DS450S DS550HS DS550S DS650HS DS650S DS750HS DS750S FR355HS FR355S FR555HS FR555S HL454S HL554S IN151HS IN151S IN251HS IN251S IN451HS IN451S IN551HS IN551S IN651HS IN651S IN751HS IN751S JP256HS JP456HS JP456S JP556HS JP556S JP656HS JP756HS JP756S KP250HS KP250S KP450HS KP450S KP550HS KP550S KP750HS KP750S LA151HS LA151S LA251HS LA251S LA451HS LA451S LA551HS LA551S LA651HS LA651S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1974-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.