# FDA recall Z-0902-2021

> **Respironics California, LLC** · Class II · device recall initiated 2020-11-02.

## Product

Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

## Reason for recall

Potential issues with ventilator navigation ring interface and liquid ingress:  1) The navigation ring may become inoperative or operate intermittently;  2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

## Distribution

Worldwide distribution - US Nationwide including Guam and Puerto Rico;  Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uk

## Key facts

- **Recall number:** Z-0902-2021
- **Recalling firm:** Respironics California, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-02
- **Report date:** 2021-02-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0902-2021

## Citation

> AI Analytics. FDA recall Z-0902-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0902-2021. Source: US FDA. Licensed CC0.

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