Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory Recalled by Breas Medical, Inc. Due to A forced shutdown of one of the processors...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Breas Medical, Inc. directly.
Affected Products
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
Quantity: 1,113 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Breas Medical, Inc.
Breas Medical, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report