Vivo 45LS Ventilator- intended to provide continuous or… recallZ-1382-2022 · Breas Medical, Inc. · initiated Jun 2, 2022
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Breas Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
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
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-1382-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 2, 2022
- Recalling firm
- Breas Medical, Inc.
- Quantity
- 1,113 units
- Product code
- NOU
- FDA submissions
- K193586
- Distribution
- Nationwide
Product description
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
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vivo 45 LS USBreas Medical AB · Ventilator, Continuous, Facility Use2 recalls6 deaths13 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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