Recall StatusTerminated
Date Initiated2021-12-20
Date Terminated2024-08-28
Product Quantity4189 units
Reason for Recall
Potential cessation in ventilation can occur under specific conditions.
Firm Action
International consignees were notified of the correction via email notification beginning 12/20/2021 containing a Field Safety Notice, an Appendix to the Field Safety Notice which lists the affected units, an FSCA Distributor Response Form and an FSCA End User Response form, all in English, with the notation that localized versions were currently in translation and will be forwarded as soon as available, if applicable. The email provided information on the affected model numbers and actions to be taken by the distributor. These actions included notifying all affected end users by providing them with the FSCA package containing the notice and the list of affected units, notify the appropriate regulatory authorities as applicable, return the completed and signed FSCA Distributor Response form, and letting them know that if any user facilities have distributed affected products to other persons or facilities, promptly forward a copy of the Field Safety Notice and the list of affected units. The email informs them that imtmedical ag will inform them of the availability of the software patch in a separate communication for installation.
The recalling firm, Vyaire Medical, issued two different notifications titled "URGENT: MEDICAL DEVICE CORRECTION" to distributors and end users on 12/23/2021 via electronic communication. Physical copies of the notification will be issued to each consignee via UPS Next Day Air delivery.
The Distributor letter informed the distributor of the issue and provided a problem description, problem root cause, and said that in order to prevent adverse health consequences associated with this failure mode during use of the bellavista 1000 and bellavista 1000e ventilators, hardware generation G6, end users are encouraged to follow the User Manual and take the immediate mitigation actions listed in the End-User Notification package. The actions to be taken by the distributor included: (1) Immediately notify all affected end users by providi
Root Cause
Software change control
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Namibia, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and Zimbabwe.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.