Breas Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1382-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 2, 2022

Date Posted: July 20, 2022

Recall Number: Z-1382-2022

Event ID: 90433

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

Status: Ongoing

Product Quantity: 1,113 units

Code Information:

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.

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated