DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab…
Medical device recall Z-1973-2021. Published in FDA’s Enforcement Report on Jul 21, 2021.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 21, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
15,357,775 (10,307,186 in US, 5,039,748 OUS) in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Serial Numbers Material Numbers: ARX900H15 ARX900S15 AUX900S15 AUX900T15 AUX900T15C BLX900H15 BLX900S15 BRX900S18 CAX900H12 CAX900S12 CAX900T12 CAX900T12C CAX900T12W DEX900H13 DEX900S13 DSX900H11 DSX900H11C DSX900H11W DSX900S11…
Every code shown here, 1,999 characters
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 CAX1130S12C CAX1130S12W CAX1130T12 CAX1130T12C CAX1130T12W CNX1025H17 CNX1025S17 CNX1025T17 CNX1030H17 CNX1030S17 CNX1030T17 CNX1130H17 CNX1130S17 CNX1130T17 CNX1131H17 CNX1131S17 CNX1131T17 DEX1025H13 DEX1025S13 DEX1030H13 DEX1030S13 DEX1130H13 DEX1130S13 DSX1030H11 DSX1030H11C DSX1030H11W DSX1030S11 DSX1030S11C DSX1030S11W DSX1030T11 DSX1030T11C DSX1030T11W DSX1130H11 DSX1130H11C DSX1130H11W DSX1130S11 DSX1130S11C DSX1130S11W DSX1130T11 DSX1130T11C DSX1130T11W EEX1030H22 EEX1030S22 EEX1130H22 EEX1130S22 ESX1030H15 ESX1030H20 ESX1030S15 ESX1030S20 ESX1130H15 ESX1130S15 EUX1025H15 EUX1025H19 EUX1025S15 EUX1025S19 EUX1030H15 EUX1030H19 EUX1030S15 EUX1030S19 EUX1125H15 EUX1125H19 EUX1125S15 EUX1125S19 EUX1130H15 EUX1130H19 EUX1130S15 EUX1130S19 FRX1030H14 FRX1030S14 FRX1130H14 FRX1130S14 GBX1030H20 GBX1030S20 GBX1130H20 GBX1130S20 IN1161PLSA INX1025H19 INX1025H19C INX1025H19W INX1025S19 INX1025S19C INX1025S19W INX1025T19 INX1025T19C INX1025T19W INX1030H19 INX1030H19C INX1030H19W INX1030S19 INX1030S19C INX1030S19W INX1030T19 INX1030T19C INX1030T19W INX1125H19 INX1125H19C INX1125H19W…
FDA’s list runs to 4,445 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Global distribution
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 14, 2021.
- FDA classified it on Jul 13, 2021.
- FDA’s Enforcement Report published it on Jul 21, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Respironics, Inc., of Murrysville, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,445 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.