Home / Recalls / Breas Medical, Inc. / Z-1382-2022

Z-1382-2022 Class II Ongoing

Recalled by Breas Medical, Inc. — North Billerica, MA

Recall Details

Product Type
Devices
Report Date
July 20, 2022
Initiation Date
June 2, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,113 units

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

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

Distribution Pattern

Nationwide

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.

Other recalls by Breas Medical, Inc.

  • Z-2690-2024 Class I — Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or i (July 25, 2024)
  • Z-0405-2024 Class II — with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, (October 13, 2023)
  • Z-0943-2022 Class II — Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models (March 21, 2022)
  • Z-1352-2020 Class II — Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an acc (January 28, 2020)
  • Z-2094-2015 Class II — Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care (November 7, 2014)