Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported July 21, 2021
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.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Respironics, Inc. recalled SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Au… - a critical-severity action.
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Au… was recalled by Philips Respironics, Inc. in July 21, 2021. Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the ai…. Check the official notice for the remedy. Verify recall #Z-1974-2021 with the FDA Devices before acting.
The recall
Philips Respironics, Inc. issued this critical-severity FDA Devices recall-The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the ai….
- Critical
- severity level
- Class I
- classification
- July 21, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1974-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1974-2021) was formally reported on July 21, 2021, with the manufacturer initiating the action on June 14, 2021. It is classified under Critical severity (Class I), with a current status of Ongoing. Philips Respironics, Inc. is listed as the recalling firm, operating out of Murrysville, PA. Federal records list the affected scope as 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Global distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
Related Recalls
6
6 from same agency
Product description
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 for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1974-2021 |
| Date reported | July 21, 2021 |
| Date initiated | June 14, 2021 |
| Recalling firm | Philips Respironics, Inc. |
| Firm location | Murrysville, PA |
| Affected scope | 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total |
| Distribution | Global distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1974-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Philips Respironics, Inc.. Units affected: 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Critical. Recall number: Z-1974-2021.
Where was the recalled product distributed? ▼
Distribution: Global distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1974-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 21, 2021.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.