Home / Recalls / Draeger Medical, Inc. / Z-0668-2025

Z-0668-2025 Class I Ongoing

Recalled by Draeger Medical, Inc. — Telford, PA

Recall Details

Product Type
Devices
Report Date
December 25, 2024
Initiation Date
October 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25 units (OUS Only)

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.

Distribution Pattern

No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.

Code Information

Model/Catalog Number: 8621400; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co., KGaA to OUS: ASTB-0051; 0053; 0054; 0055; 0063; 0065; 0093; 0162 ASTE-0219; 0220; 0221; 0222; 0377 ASTF-0472; 0473 ASTH-0005; 0006; 0026; 0027; 0047; 0186; 0223; 0224; 0401 ASTJ-0170

Other recalls by Draeger Medical, Inc.

  • Z-0667-2025 Class I — Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 (October 15, 2024)
  • Z-0305-2025 Class I — Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 So (October 15, 2024)
  • Z-0304-2025 Class I — Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Soft (October 15, 2024)
  • Z-1512-2024 Class I — Dr¿ger Perseus A500 Anesthesia Workstation (March 20, 2024)
  • Z-2248-2023 Class I — Carina Sub-Acute Care Ventilator (July 12, 2023)
  • Z-2018-2023 Class I — Oxylog 3000 Plus emergency and transport ventilator (June 12, 2023)
  • Z-1449-2023 Class I — VentStar Watertrap (N) 180, MP00363 (April 17, 2023)
  • Z-1458-2023 Class I — Anesthesia Set Coax 180, MP03384 (April 17, 2023)
  • Z-1460-2023 Class I — Anesthesia Circuit Kit Coax HEPA, MP17102 (April 17, 2023)
  • Z-1455-2023 Class I — Ventstar Coax 180, MP03374 (April 17, 2023)