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
Recall
- Recall Number
- Z-1382-2022
- Event Number
- 90433
- Firm
- Breas Medical, Inc.
- FEI Number
- 3010817335
- Product Code
- NOU
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- June 2, 2022
- Address
- 16 Esquire Rd, North Billerica, MA, 01862-2527
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
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 contacted consignees initially by phone beginning 6/2/22 followed by email Urgent Medical Device Recall Firmware Upgrade letter Letter states reason for recall, health risk and action to take: Customers are required to identify all affected Vivo 45 LS ventilators and apply the firmware upgrade to firmware version 5.0.7 (or later) within 12 months. Breas has implemented a firmware correction to resolve the problem and can confirm that Vivo 45LS with firmware versions 5.0.7 or higher, distributed after March 29th, 2022 are not affected by this issue. Confirmation of receipt We kindly ask you to acknowledge receipt of this Recall Notice together with your choice to remedy the issue using attached reply form Vivo 45 LS Firmware Upgrade Customer Reply Form. Helpline +1 (855) 436-8724
Nationwide
1,113 units