Z-1382-2022Class II

Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of...

Name: Z-1382-2022 Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of...
Creator: Breas Medical, Inc.
Published: 2022-06-02
License: https://open.fda.gov/license/

Breas Medical AB / initiated 2022-06-02 / Open, Classified / root cause: design

FDA source

Breas Medical, Inc. began a recall of Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model... on 2022-06-02. FDA classified it as Class II and gives the reason as "A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1382-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-02
Posted: 2022-07-13
Recalling firm: Breas Medical AB
Product: Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
Product code: NOU Continuous, Ventilator, Home Use
Reason for recall: A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
Root cause tag: design
FDA root cause: Device Design
Action: Breas Medical contacted consignees initially by phone beginning 6/2/22 followed by email Urgent Medical Device Recall Firmware Upgrade letter Letter states reason for recall, health risk and action to take: Customers are required to identify all affected Vivo 45 LS ventilators and apply the firmware upgrade to firmware version 5.0.7 (or later) within 12 months. Breas has implemented a firmware correction to resolve the problem and can confirm that Vivo 45LS with firmware versions 5.0.7 or higher, distributed after March 29th, 2022 are not affected by this issue. Confirmation of receipt We kindly ask you to acknowledge receipt of this Recall Notice together with your choice to remedy the issue using attached reply form Vivo 45 LS Firmware Upgrade Customer Reply Form. Helpline +1 (855) 436-8724
Quantity in commerce: 1,113 units
Distribution: Nationwide
Product codes and lots: Unique Device Identifier (UDI): UDI 07321822300004. Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1382-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1382-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-13

Product code NOU

K193586Class IIVivo 45 LSBreas Medical AB / cleared 2021-01-27

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)