Z-1439-2020Class II

bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic...

Name: Z-1439-2020 bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic...
Creator: Vyaire Medical
Published: 2019-11-25
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2019-11-25 / Terminated / root cause: software

FDA source

Vyaire Medical began a recall of bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air... on 2019-11-25. FDA classified it as Class II and gives the reason as "The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen". 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-1439-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-25
Posted: 2020-03-04
Terminated: 2023-08-08
Recalling firm: Jaeger Medical GmbH
Product: bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor controlled inspiratory valve.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were sent an Urgent Medical Device Recall letter beginning 11/25/2019 via overnight delivery. The letter identified affected devices, provided a description of the issue, and provided actions to be taken by distributors and end-users. A response form was asked to be returned. Questions can be directed to Vyaire's Technical Support Department at [email protected].
Quantity in commerce: 116
Distribution: US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.
Product codes and lots: Serial numbers: MB170104, MB170118, MB170151, MB170202, MB230000, MB230020, MB230024, MB230027, MB230031, MB230033, MB230035, MB230036, MB230037, MB230038, MB230039, MB230040, MB230041, MB230046, MB230048, MB230049, MB230052, MB230053, MB230054, MB230055, MB230056, MB230057, MB230058, MB230059, MB230060, MB230061, MB230062, MB230063, MB230064, MB230065, MB230066, MB230067, MB230068, MB230069, MB230070, MB230071, MB230072, MB230073, MB230074, MB230075, MB230076, MB230077, MB230078, MB230079, MB230080, MB230081, MB230082, MB230083, MB230084, MB230085, MB230086, MB230087, MB230088, MB230089, MB230090, MB230091, MB230092, MB230093, MB230094, MB230095, MB230097, MB230098, MB230099, MB230100, MB230101, MB230102, MB230104, MB230190, MB230191, MB230194, MB230195, MB230196, MB230197, MB230201, MB230204, MB230205, MB230207, MB230209, MB230210, MB230217, MB230219, MB230220, MB230221, MB230222, MB230227, MB230228, MB230229, MB230230, MB230231, MB230232, MB230233, MB230243, MB230244, MB230246, MB230247, MB230249, MB230251, MB230253, MB230256, MB230258, MB230260, MB230261, MB230262, MB230263, MB230266, MB230270, MB230274, MB230275, MB230277, MB230294, MB230297, MB230298.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1439-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1439-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-04

Product code CBK

K163127Class IIbellavista 1000Imtmedical AG / cleared 2017-07-31

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)