Z-0909-2021 Class II Ongoing
FDA device recall Z-0909-2021 was initiated by Respironics California, LLC on November 2, 2020 and is designated Class II. 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 pa… The recall status is ongoing. Affected quantity: 3 systems.
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2021
- Initiation Date
- November 2, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 systems
Product Description
Reason for Recall
Distribution Pattern
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, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.