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
Check against the official notice below — it lists the full affected range.
Breas Medical, Inc. is recalling 1,113 units of the Vivo 45LS Ventilator (Model Number 230000) nationwide. The device is designed to provide continuous or intermittent mechanical ventilation support for patients who require it. The recall involves specific serial number ranges: D, K, and M01 through M040124 (where asterisks represent any digit 0-9), identified by Unique Device Identifier UDI 07321822300004.
The ventilator has a safety defect in which a forced shutdown of one of its processors may not trigger a watchdog alarm, potentially leading to device failure. If this occurs and a patient's ventilator-dependent status is not being closely monitored according to the device instructions, the consequences could be permanent impairment or life-threatening conditions requiring medical intervention. The recall notice does not specify a remedy.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: Nationwide Quantity: 1,113 units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.