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U.S. Department of Health and Human Services

Class 1 Device Recall Atlan

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 Class 1 Device Recall Atlansee related information
Date Initiated by FirmSeptember 09, 2025
Date PostedOctober 01, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2617-2025
Recall Event ID 97525
510(K)NumberK230931 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductBrand 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
Code Information Lot Code: UDI-DI Number: 04048675556183 Serial Numbers Distributed in the US: ASTA-0307,ASTA-0309,ASTA-0311,ASTA-0349,ASTA-0350,ASTA-0409 ASTB-0048 ASTC-0244,ASTC-0245 ASTD-0008,ASTD-0009,ASTD-0010,ASTD-0011,ASTD-0013,ASTD-0014,ASTD-0212,ASTD-0239 ASTH-0307,ASTH-0308,ASTH-0309,ASTH-0310,ASTH-0311,ASTH-0332,ASTH-0333,ASTH-0334, ASTH-0335,ASTH-0336,ASTH-0383,ASTH-0384 ASTJ-0014 ASUA-0469,ASUA-0483,ASUA-0484,ASUA-0486,ASUA-0488 ASUB-0093,ASUB-0169,ASUB-0170,ASUB-0171,ASUB-0172,ASUB-0173,ASUB-0174,ASUB-0175, ASUB-0176,ASUB-0183,ASUB-0184,ASUB-0185,ASUB-0186,ASUB-0187,ASUB-0215,ASUB-0216, ASUB-0217,ASUB-0218,ASUB-0219,ASUB-0221,ASUB-0222,ASUB-0250,ASUB-0251,ASUB-0266, ASUB-0267, ASUB-0268,ASUB-0269,ASUB-0270 ASUC-0067,ASUC-0068,ASUC-0069,ASUC-0072,ASUC-0114,ASUC-0115,ASUC-0146,ASUC-0148, ASUC-0149,ASUC-0150,ASUC-0151,ASUC-0153,ASUC-0155,ASUC-0156,ASUC-0157,ASUC-0158, ASUC-0174,ASUC-0175,ASUC-0176,ASUC-0178,ASUC-0179,ASUC-0180,ASUC-0181,ASUC-0182, ASUC-0183,ASUC-0184,ASUC-0185,ASUC-0186,ASUC-0187,ASUC-0188,,ASUC-0189,ASUC-0190, ASUC-0191,ASUC-0192,ASUC-0193,ASUC-0194,ASUC-0196,ASUC-0197,ASUC-0198,ASUC-0199, ASUC-0200,ASUC-0201,ASUC-0202,ASUC-0211,ASUC-0212,ASUC-0213,ASUC-0214,ASUC-0215, ASUC-0216,ASUC-0217,ASUC-0238,ASUC-0239,ASUC-0285,ASUC-0368,ASUC-0369,ASUC-0370, ASUC-0371,ASUC-0372,ASUC-0373 ASUD-0142,ASUD-0142,ASUD-0143,ASUD-0143,ASUD-0144,ASUD-0145,ASUD-0146,ASUD-0147, ASUD-0164,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0187,ASUD-0188,ASUD-0189, ASUD-0190,ASUD-0191,ASUD-0192,ASUD-0193,ASUD-0207,ASUD-0208,ASUD-0209,ASUD-0210, ASUD-0211,ASUD-0212,ASUD-0212,ASUD-0275,ASUD-0276,ASUD-0277,ASUD-0294 Serial Numbers Distributed OUS (Direct shipped from Draegerwerk AG & Co., KGaA): ASUB-0094,ASUB-0279,ASUB-0280,ASUB-0281,ASUB-0282,ASUB-0284,ASUB-0285,ASUB-0286, ASUC-0005,ASUC-0006,ASUC-0007,ASUC-0008,ASUC-0010,ASUC-0011,ASUC-0012,ASUC-0013, ASUC-0014,ASU-0042,ASUC-0043,ASUC-0044,ASUC-0045,ASUC-0046,ASUC-0047,ASUC-0048, ASUC-0049,ASUC-0050,ASUC-0051,ASUC-0052,ASUC-0053,ASUC-0054,ASUC-0057,ASUC-0060, ASUC-0073,ASUC-0074,ASUC-0075,ASUC-0076,ASUC-0077,ASUC-0078,ASUC-0079,ASUC-0080, SUC-0081,ASUC-0082,ASUC-0331,ASUC-0377,ASUC-0378,ASUC-0379,ASUD-0067,ASUD-0068, ASUD-0088,ASUD-0089,ASUD-0091,ASUD-0092,ASUD-0093,ASUD-0094,ASUD-0095,ASUD-0096, ASUD-0097,ASUD-0112,ASUD-0113,ASUD-0114,ASUD-0115,ASUD-0116,ASUD-0117,ASUD-0118, ASUD-0119,ASUD-0120,ASUD-0121,ASUD-0122,ASUD-0160,ASUD-0166
Recalling Firm/
Manufacturer		 Draeger, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactMichael Kelhart
01-267-6641131
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 09/09/2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. Actions to be taken: - The corrective action is for a Drger Service Representative to inspect, and, if necessary, replace the ventilator motor assembly. You will be contacted by your local Drger Service Representative to arrange a date for the ventilator motor assembly inspection and, if necessary, replacement. - 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 Drger 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 this Urgent Medical Device Correction notice, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com. Adverse events or quality problems experienced with the use of this product may be reported to FDA s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by phone at 1-800-FDA-1088.
Quantity in Commerce223
DistributionDevices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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