Z-0870-2022 Class II Terminated

Recalled by Draeger Medical, Inc. — Telford, PA

Recall Details

Product Type
Devices
Report Date
April 13, 2022
Initiation Date
February 14, 2022
Termination Date
January 7, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,337 (10,728 units US)

Product Description

Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400

Reason for Recall

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Distribution Pattern

US Nationwide

Code Information

All Lots/Serial Numbers. UDI: 04048675042266