Home / Recalls / Draeger Medical, Inc. / Z-0305-2025

Z-0305-2025 Class I Ongoing

Recalled by Draeger Medical, Inc. — Telford, PA

FDA device recall Z-0305-2025 was initiated by Draeger Medical, Inc. on October 15, 2024 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 455 units (310 units US, 145 OUS).

Recall Details

Product Type
Devices
Report Date
November 20, 2024
Initiation Date
October 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
455 units (310 units US, 145 OUS)

Product Description

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

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

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, 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, Vietnam.

Code Information

Model/Catalog Number: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 0311; 0349; 0350; 0351; 0353; 0363; 0365; 0394; 0408; 0409 ASTB-0048; 0286; 0287; 0288; 0289; 0290; 0291; 0304; 0305; 0306; 0307; 0308; 0309; 0317; 0318; 0319; 0320; 0321; 0322 ASTC-0006; 0007; 0068; 0069; 0070; 0082; 0083; 0099; 0100; 0101; 0105; 0106; 0107; 0108; 0109; 0118; 0119; 0136; 0137; 0229; 0230; 0243; 0244; 0245 ASTD-0008; 0009; 0010; 0011; 0012; 0013; 0014; 0129; 0130; 0131; 0132; 0133; 0134; 0135; 0154; 0159; 0160; 0161; 0162; 0163; 0164; 0165; 0166; 0167; 0168; 0169; 0181; 0182; 0183; 0193; 0194; 0195; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245 ASTE-0016; 0017; 0077; 0078; 0079; 0086; 0087; 0122; 0123; 0124; 0125; 0126; 0129; 0130; 0131; 0163; 0164; 0165; 0166; 0171; 0172; 0173; 0174; 0195; 0196; 0197; 0198; 0203; 0225; 0226; 0246; 0247; 0248; 0249; 0250; 0278; 0279; 0280; 0281; 0301; 0302; 0303; 0304; 0305; 0306; 0348; 0349; 0350; 0351; 0352; 0357; 0358; 0359; 0360; 0361; 0362 ASTF-0001; 0002; 0003; 0004; 0014; 0015; 0016; 0017; 0018; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0055; 0061; 0062; 0063; 0070; 0071; 0076; 0077; 0078; 0079; 0080; 0081; 0121; 0122; 0123; 0124; 0125; 0135; 0136; 0137; 0138; 0139; 0140; 0141; 0168; 0169; 0170; 0194; 0195; 0196; 0409; 0410; 0411; 0436; 0437; 0438; 0474; 0475; 0476; 0477; 0478 ASTH-0007; 0008; 0009; 0010; 0011; 0012; 0092; 0093; 0094; 0095; 0096; 0120; 0121; 0122; 0123; 0124; 0125; 0126; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0169; 0170; 0171; 0172; 0173; 0174; 0175; 0187; 0188; 0189; 0190; 0191; 0192; 0269; 0270; 0271; 0272; 0273; 0293; 0294; 0295; 0296; 0306; 0307; 0308; 0309; 0310; 0311; 0324; 0325; 0326; 0327; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0358; 0359; 0360; 0361; 0362; 0363; 0364; 0365; 0383; 0384; 0385; 0386; 0387; 0388; 0389; 0390; 0450; 0476; 0477; 0478; 0479; 0480; 0481; 0488; 0489; 0490; 0491 Serial Numbers Distributed OUS: ASTA-0253; 0289; 0290; 0327; 0362; 0404; 0405; 0426; 0427; 0428; 0429; 0430 ASTB-0003; 0005; 0007; 0028; 0029; 0030; 0031; 0032; 0033; 0075; 0076; 0077; 0079; 0080; 0081; 0082; 0083; 0084; 0134; 0195; 0206; 0219; 0220; 0237 ASTC-0001; 0002; 0003; 0004; 0026; 0138; 0163; 0180; 0181; 0194; ASTD-0015; 0016; 0050; 0061; 0062; 0063; 0064; 0065; 0066; 0203; 0204; 0205; 0265; 0266; 0267 ASTE-0034; 0035; 0057; 0058; 0059; 0060; 0062; 0085; 0108; 0127; 0128; 0175; 0202; 0223; 0224; 0300; 0325; 0326; 0327; 0328; 0329; 0353; 0354; 0355; 0356 ASTF-0051; 0052; 0053; 0054; 0112; 0113; 0435; 0471 ASTH-0039; 0040; 0045; 0046; 0081; 0082; 0176; 0193; 0194; 0204; 0217; 0218; 0219; 0225; 0226; 0243; 0244; 0245; 0246; 0255; 0256; 0382; 0403; 0404; 0405; 0406; 0434; 0435; 0436; 0437; 0451; 0452; 0453; 0 ASTJ-0063; 0064; 0065; 0066; 0067; 0068; 0089; 0090; 0091; 0092; 0145; 0146; 0147; 0171; 0237 ASTK-0002

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-0668-2025 Class I — Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 (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-1450-2023 Class I — VentStar Bag Set (N) 110, MP00383 (April 17, 2023)
  • Z-1449-2023 Class I — VentStar Watertrap (N) 180, MP00363 (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)

FDA data resources