Recall Z-2616-2025— Draeger, Inc.
Class I · Ongoing
Class I FDA medical device recall by Draeger, Inc., initiated 2025-09-09. It names one FDA 510(k) clearance: K230931. Product: Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable. Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use..
- Recalling firm
- Draeger, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-09-09
- 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 A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable
Reason for recall
The device 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.