Z-0871-2022 Class II Terminated
FDA device recall Z-0871-2022 was initiated by Draeger Medical, Inc. on Feb 14, 2022 and is designated Class II. Reason for recall: Cybersecurity Improvement Action-not equipped against potential cyber security threats The recall status is terminated (terminated Jan 7, 2025). Affected quantity: 13,687 (2,987 units US).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Feb 14, 2022
- Termination Date
- Jan 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,687 (2,987 units US)
Product Description
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
Reason for Recall
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Distribution Pattern
US Nationwide
Code Information
All Lots/Serial Numbers. UDI: 04048675250418
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0871-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026