Z-0622-2022Class I

bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista...

Name: Z-0622-2022 bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista...
Creator: Vyaire Medical
Published: 2021-12-20
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2021-12-20 / Terminated / root cause: software

FDA source

Vyaire Medical began a recall of bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide... on 2021-12-20. FDA classified it as Class I and gives the reason as "Potential cessation in ventilation can occur under specific conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0622-2022
Classification: Class I
Status: Terminated
Initiated: 2021-12-20
Posted: 2022-02-16
Terminated: 2024-08-28
Recalling firm: Jaeger Medical GmbH
Product: bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Potential cessation in ventilation can occur under specific conditions.
Root cause tag: software
FDA root cause: Software change control
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
Quantity in commerce: 4189 units
Distribution: 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.
Product codes and lots: Hardware generation G6, software version V6.0.1600.0 or higher installed, all serial numbers. UDI 07640149381115 (bellavista 1000 ventilator) and 07640149388879 (bellavista 1000e ventilator).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0622-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0622-2022	Class I	Terminated	Voluntary: Firm initiated	2022-02-23	2022-02-16

Product code CBK

K183364Class IIBellavistaImtmedical AG / cleared 2019-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)