Z-0304-2025Class I

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable...

Name: Z-0304-2025 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable...
Creator: Draeger Medical, Inc.
Published: 2024-10-15
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2024-10-15 / Open, Classified / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable on 2024-10-15. FDA classified it as Class I and gives the reason as "The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0304-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-15
Posted: 2024-11-13
Recalling firm: Draeger, Inc.
Product: Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 15, 2024 Urgent Medical Device Correction letters were sent to customers. Necessary Action: The corrective action is to replace the ventilator motor assembly. You will be contacted by your local Draeger Service Representative to arrange a date for the ventilator motor assembly replacement. Until the corrective action is implemented, you may continue operating your devices with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use. If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient manually as needed. Monitor the patient s condition specifically their oxygenation status as a brief cessation of ventilation can potentially lead to e.g.; hypoxia, loss of lung recruitment, bradycardia and cardiac arrest. If preferred, the alarm priority of the "Ventilator error!!!" can be downgraded with "ALARM RESET" after switching to Man/Spont ventilation mode. Identification of affected medical devices: According to our records, you have received at least one Atlan anesthesia workstation manufactured by Draegerwerk AG & Co. KGaA that may be affected by this issue. Please refer to the attached list of affected serial numbers. Please ensure that all users of the Drger Atlan as well as other persons concerned within your organization are made aware of this Urgent Medical Device Correction notice. Please complete and return the attached Medical Device Correction Return Response Acknowledgment and Receipt Form to confirm that you have received this information. If you have made the products available to third parties, please forward this Urgent Medical Device Correction notice to them. If you have any questions regarding the operation of your Atlan A350/A350XL anesthesia workstation, please contact Draeger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 2 again). If you have any questions regarding
Quantity in commerce: 1,492 units (139 units US, 1,353 OUS)
Distribution: 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.
Product codes and lots: Model/Catalog Number: 8211500; UDI-DI Number: 04048675556176; Serial Numbers Distributed in the US: ASTB-0038; 0039; 0146; 0147; 0148; 0281; 0282; 0283; 0300; 0301; 0302; 0303; 0312; 0313; 0314; 0315; 0316 ASTC-0005; 0094; 0095; 0190; 0191 ASTD-0029; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0038; 0039; 0040; 0041; 0042; 0043; 0044; 0045; 0046 0057; 0136; 0137; 0138; 0139; 0140; 0141; 0142; 0143; 0148; 0149; 0150; 0151; 0152; 0153; 0155; 0156; 0157; 0158; 0170; 0171; 0186; 0235; 0236; 0237; 0257; 0258; 0259 ASTE-0002; 0003; 0004; 0005; 0006; 0007; 0008; 0029; 0030; 0031; 0032; 0080; 0134; 0135; 0136; 0152; 0153; 0154; 0155; 0180; 0181; 0209; 0210; 0211; 0212; 0213; 0214; 0215; 0216; 0217; 0218; 0254; 0255; 0318; 0319; 0320; 0321; 0322 ASTF-0007; 0008; 0009; 0010; 0145; 0146; 0147; 0148; 0149; 0150; 0177; 0178; 0379; 0380 ASTH-0083; 0084; 0107; 0160; 0161; 0184; 0185; 0207; 0208; 0233; 0241; 0242; 0254; 0370; 0392; 0432; 0464 Serial Numbers Distributed OUS ASTA-0279; 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0304-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0304-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13
Z-0305-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13

Product code BSZ

K230931Class IIAtlanDrägerwerk AG Co. Kgaa / cleared 2023-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)