Recall Z-0668-2025— Draeger Medical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2024-10-15. It names one FDA 510(k) clearance: K230931. Product: Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.. Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-10-15
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Reason for recall
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.