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Draeger Medical, Inc. Recall 89702

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

Draeger Medical, Inc. Recall 89702 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0870-2022
Event ID89702
Event DescriptionEvita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Product TypeDevices
DistributionUS Nationwide
Quantity24,337 (10,728 units US)
Recall ReasonCybersecurity Improvement Action-not equipped against potential cyber security threats
Device Classification20220413
Device Code InfoAll Lots/Serial Numbers. UDI: 04048675042266
Center Classification Date20220404
Recall Initiation Date20220214
Recalling FirmDraeger Medical, Inc.
Initial Notification Letter
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