SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous…
Medical device recall Z-1974-2021. 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?
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.
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: 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…
Every code shown here, 1,993 characters
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 LA751HS LA751S RIN551S RJP556S SH558HS SH558S UODS150S UODS250S UODS450S UODS550S UODS560S UODS650S UODS750S RTODS650HS 151BR LA151SBR 151P 157P 250P 251BR LA251SBR RBRLA251SBR 251P RBRLA251HS RBRLA251S 255P FR255HS FR255S 257P 355P 450P 451BR LA451SBR RBRLA451SBR 451P RIN451S RBRLA451HS RBRLA451S 452P UDE452S 454P 456P RJP456S 457P 550P 551BR LA551SBR RBRLA551SBR 551P RBRLA551HS RBRLA551S 552P UDE552S 554P 555P 556P 557P 651BR LA651SBR RBRLA651S RBRLA651SBR 651P 657P 750P 751BR LA751SBR RBRLA751SBR 751P RBRLA751HS RBRLA751S 752P 756P RJP756S 757P AU151H CA151 CA151H CA451HC CA451W CA551C CA551HC CN157 DS150 DS450C DS450D DS550C DS550HC KP450C KP450HC KP550C KP550HC RDS150S RDS250S RDS450S RDS520S RDS550HS RDS550S RDS650S RDS750HS RDS750S RIN751S UDS150S UDS250S UDS450S UDS520S UDS550S UDS650S UDS750S AHX200H11 AHX200H11C AHX200H11W AHX200S11 AHX200T11 AHX200T11C AHX200T11W AHX400H11 AHX400H11C AHX400H11W AHX400S11 AHX400T11 AHX400T11C AHX400T11W AHX500H11 AHX500H11C AHX500H11W AHX500S11 AHX500T11 AHX500T11C AHX500T11W AHX600H11 AHX600H11C AHX600H11W AHX600S11 AHX600T11 AHX600T11C AHX600T11W…
FDA’s list runs to 6,804 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 6,804 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
-
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.