Breas Medical recalls Vivo 45LS ventilators with firmware 5.0.5 or earlier that may shut down without warning, risking permanent harm or death if not fixed.
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
Breas Medical is recalling its Vivo 45LS ventilators because a software issue could cause the device to shut down without warning, potentially leading to serious health consequences if the patient isn't monitored properly.
The ventilator's processor may shut down without triggering a warning, and if medical staff don't follow proper monitoring procedures, the patient could suffer permanent injury or death.
Individuals using the Vivo 45LS ventilator for medical care are affected. Patients relying on this device for breathing support are most at risk.
Check for model number 230000, firmware version 5.0.5 or earlier, or serial numbers starting with D, K, or M01 to M040124.
Immediately stop using the Vivo 45LS ventilator if it has firmware version 5.0.5 or earlier.
Firmware versions 5.0.5 or earlier.
Check for model number 230000, firmware version 5.0.5 or earlier, or serial numbers starting with D, K, or M01 to M040124.
Stop using it now and contact Breas Medical for a replacement or repair.
We’ve drafted a message you can send Breas Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1382-2022 — Breas Medical Breas Medical Hello, I own a Breas Medical that is covered by recall Z-1382-2022 from Breas Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
