Z-1382-2022 Class II Ongoing
FDA device recall Z-1382-2022 was initiated by Breas Medical, Inc. on June 2, 2022 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 1,113 units.
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.