Product Safety Recalls

Product Recall Tracker

Breas Medical, Inc. Recall 90433

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

Breas Medical, Inc. Recall 90433 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1382-2022
Event ID90433
Event DescriptionVivo 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 TypeDevices
DistributionNationwide
Quantity1,113 units
Recall ReasonA 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
Device Classification20220720
Device Code InfoUnique 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.
Center Classification Date20220713
Recall Initiation Date20220602
Recalling FirmBreas Medical, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.