# FDA recall Z-1646-2026

> **Philips Respironics, Inc.** · Class I · device recall initiated 2026-03-02.

## Product

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

## Reason for recall

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

## Distribution

Worldwide Distribution.  US Nationwide, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jersey, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Montenegro, North Macedonia, Myanmar, Martinique, Malta, Mexico, Malaysia, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe.

## Key facts

- **Recall number:** Z-1646-2026
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-02
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murrysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2026

## Citation

> AI Analytics. FDA recall Z-1646-2026. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1646-2026. Source: US FDA. Licensed CC0.

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