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bellavista 1000 ventilator, Catalog #301.100.030 and… recallZ-0622-2022 · Vyaire Medical · initiated Dec 20, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Vyaire Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential cessation in ventilation can occur under specific conditions.

FDA root cause category: Software change control

What the company is doing

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

Recall details

Recall number
Z-0622-2022
Status
Terminated
Initiated by the company
Dec 20, 2021
Posted by the FDA
Feb 16, 2022
Recalling firm
Vyaire Medical
Quantity
4189 units
Product code
CBK
FDA submissions
K183364
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 description

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.

Code information (models, lots, serial numbers)

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).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K183364 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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