Recall Z-0870-2022— Draeger Medical, Inc.

Name: FDA recall Z-0870-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-14

Class II · Terminated

Class II FDA medical device recall by Draeger Medical, Inc., initiated 2022-02-14, terminated 2025-01-07. It names one FDA 510(k) clearance: K093633. Product: Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400. Reason: Cybersecurity Improvement Action-not equipped against potential cyber security threats.

Recalling firm: Draeger Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-02-14
Terminated: 2025-01-07
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K093633 — INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CAREDraegerwerk AG & CO Kgaa·cleared 2010-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.