Recall Z-2617-2025— Draeger, Inc.

Name: FDA recall Z-2617-2025
Creator: U.S. Food and Drug Administration
Published: 2025-09-09

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 A350XL Model/Catalog Number: 8621600 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 record

K230931 — AtlanDrägerwerk AG Co. Kgaa·cleared 2023-07-23

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

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 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.