FDA Device recall Z-1973-2021
DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, No…
- FDA Device
- Class I
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class I recall of DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, No… 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-1973-2021 |
| 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
DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting 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: ARX900H15 ARX900S15 AUX900S15 AUX900T15 AUX900T15C BLX900H15 BLX900S15…All Serial Numbers Material Numbers: ARX900H15 ARX900S15 AUX900S15 AUX900T15 AUX900T15C BLX900H15 BLX900S15 BRX900S18 CAX900H12 CAX900S12 CAX900T12 CAX900T12C CAX900T12W DEX900H13 DEX900S13 DSX900H11 DSX900H11C DSX900H11W DSX900S11 DSX900T11 DSX900T11C DSX900T11W EEX900H15 EEX900S15 ESX900H15 ESX900S15 EUX900H15 EUX900H19 EUX900S15 EUX900S19 FRX900H14 FRX900S14 FRX900S14W GBX900H15 GBX900S15 INX900H19 INX900S19 INX900T19 ITX900H15 ITX900S15 JPX900S16 LAX900H19 LAX900S19 LAX900T19 NDX900H15 NDX900S15 PPX900S10 RGBX900S15 TRX900H15 TRX900S15 UAX900S15 UCDSX900S11 ZAX900H19 ZAX900S19 BRX900S18 RDEX900S13 RDEX900H13 RGBX900H15 TRX900H15 RDSX900S11 RFRX900S14 RJPX900S16 UDSX900S11 AUX1131H15 AUX1131H15C AUX1131H15W AUX1131S15 AUX1131S15C AUX1131S15W AUX1131T15 AUX1131T15C AUX1131T15W BLX1030H15 BLX1030S15 BLX1130H15 BLX1130S15 BRX1030S18 BRX1130S18 CAX1130H12 CAX1130H12C CAX1130H12W CAX1130S12 |
|---|
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-1973-2021%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.