The Recall Desk
HighFDA (Devices)·Z-1382-2022·Announced 2022-07-20

Vivo 45LS Ventilator processor failure alarm not generated on shutdown

Breas Medical recalls 1,113 Vivo 45LS Ventilators due to a processor that can fail without triggering an alarm, potentially preventing detection of ventilator malfunction if monitoring instructions are not followed.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device (ventilator used for life support) where processor failure could result in permanent impairment or life-threatening condition. The source explicitly states the hazard is theoretical—consequences 'could potentially' occur—with no reported illnesses or injuries, placing this at the High severity level.

Plain-English summary

Breas Medical, Inc. is recalling 1,113 Vivo 45LS Ventilators (Model 230000) with firmware versions 5.0.5 or earlier. These devices are intended to provide continuous or intermittent mechanical ventilation support for patients requiring respiratory assistance. Affected units are distributed nationwide.

The recalled ventilators have a defect in which a forced shutdown of one of the processors does not generate a watchdog alarm. This means a critical processor failure could occur without alerting medical staff or caregivers who are monitoring the patient.

If ventilator-dependent patients are not monitored closely per manufacturer instructions and a processor failure occurs undetected, the health consequences could potentially result in permanent impairment or a life-threatening condition requiring immediate medical intervention. Patients and healthcare facilities using affected serial number ranges (D******, K******, M01**** to M040124, UDI 07321822300004) should verify their device and contact Breas Medical for further instructions on remediation or replacement.

The recalled product

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
Manufacturer
Breas Medical, Inc.
Category
Medical Device — Respiratory Support Equipment
Hazard
  • processor-failure
  • alarm-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • K******
  • M01**** to M040124
  • where asterisk (*) denotes a digit from 0 to 9.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category