Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported June 14, 2023
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Respironics, Inc. recalled Trilogy Evo Universal Ventilator, Model Number DS2000X11B - a critical-severity action.
Trilogy Evo Universal Ventilator, Model Number DS2000X11B was recalled by Philips Respironics, Inc. in June 14, 2023. Reason: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for th…. Check the official notice for the remedy. Verify recall #Z-1652-2023 with the FDA Devices before acting.
The recall
Philips Respironics, Inc. issued this critical-severity FDA Devices recall-The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for th….
- Critical
- severity level
- 22K units
- affected scope
- Class I
- classification
- June 14, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1652-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1652-2023) was formally reported on June 14, 2023, with the manufacturer initiating the action on May 1, 2023. 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 22,237 devices.
The documented reason for this recall is: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric thro… Distribution data in the federal record shows the product reached: US Nationwide. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
22,237 devices
Related Recalls
6
3 from same agency
Product description
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Reason for recall
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1652-2023 |
| Date reported | June 14, 2023 |
| Date initiated | May 1, 2023 |
| Recalling firm | Philips Respironics, Inc. |
| Firm location | Murrysville, PA |
| Affected scope | 22,237 devices |
| Distribution | US Nationwide. 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-1652-2023) 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? ▼
Trilogy Evo Universal Ventilator, Model Number DS2000X11B. Recalled by Philips Respironics, Inc.. Units affected: 22,237 devices.
Why was this product recalled? ▼
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Critical. Recall number: Z-1652-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Global Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1652-2023) 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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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 14, 2023. 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 July 2026.