Draeger, Inc. recalls Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 applicableUDI-DI Number224 affected lots04048675556183ASTA-0307ASTA-0309ASTA-0311ASTA-0349ASTA-0350ASTA-0409ASTB-0048
+216 more
ASTC-0244ASTC-0245ASTD-0008ASTD-0009ASTD-0010ASTD-0011ASTD-0013ASTD-0014ASTD-0212ASTD-0239ASTH-0307ASTH-0308ASTH-0309ASTH-0310ASTH-0311ASTH-0332ASTH-0333ASTH-0334ASTH-0335ASTH-0336ASTH-0383ASTH-0384ASTJ-0014ASUA-0469ASUA-0483ASUA-0484ASUA-0486ASUA-0488ASUB-0093ASUB-0169ASUB-0170ASUB-0171ASUB-0172ASUB-0173ASUB-0174ASUB-0175ASUB-0176ASUB-0183ASUB-0184ASUB-0185ASUB-0186ASUB-0187ASUB-0215ASUB-0216ASUB-0217ASUB-0218ASUB-0219ASUB-0221ASUB-0222ASUB-0250ASUB-0251ASUB-0266ASUB-0267ASUB-0268ASUB-0269ASUB-0270ASUC-0067ASUC-0068ASUC-0069ASUC-0072ASUC-0114ASUC-0115ASUC-0146ASUC-0148ASUC-0149ASUC-0150ASUC-0151ASUC-0153ASUC-0155ASUC-0156ASUC-0157ASUC-0158ASUC-0174ASUC-0175ASUC-0176ASUC-0178ASUC-0179ASUC-0180ASUC-0181ASUC-0182ASUC-0183ASUC-0184ASUC-0185ASUC-0186ASUC-0187ASUC-0188ASUC-0189ASUC-0190ASUC-0191ASUC-0192ASUC-0193ASUC-0194ASUC-0196ASUC-0197ASUC-0198ASUC-0199ASUC-0200ASUC-0201ASUC-0202ASUC-0211ASUC-0212ASUC-0213ASUC-0214ASUC-0215ASUC-0216ASUC-0217ASUC-0238ASUC-0239ASUC-0285ASUC-0368ASUC-0369ASUC-0370ASUC-0371ASUC-0372ASUC-0373ASUD-0142ASUD-0142ASUD-0143ASUD-0143ASUD-0144ASUD-0145ASUD-0146ASUD-0147ASUD-0164ASUD-0165ASUD-0165ASUD-0165ASUD-0165ASUD-0187ASUD-0188ASUD-0189ASUD-0190ASUD-0191ASUD-0192ASUD-0193ASUD-0207ASUD-0208ASUD-0209ASUD-0210ASUD-0211ASUD-0212ASUD-0212ASUD-0275ASUD-0276ASUD-0277ASUD-0294ASUB-0094ASUB-0279ASUB-0280ASUB-0281ASUB-0282ASUB-0284ASUB-0285ASUB-0286ASUC-0005ASUC-0006ASUC-0007ASUC-0008ASUC-0010ASUC-0011ASUC-0012ASUC-0013ASUC-0014ASU-0042ASUC-0043ASUC-0044ASUC-0045ASUC-0046ASUC-0047ASUC-0048ASUC-0049ASUC-0050ASUC-0051ASUC-0052ASUC-0053ASUC-0054ASUC-0057ASUC-0060ASUC-0073ASUC-0074ASUC-0075ASUC-0076ASUC-0077ASUC-0078ASUC-0079ASUC-0080SUC-0081ASUC-0082ASUC-0331ASUC-0377ASUC-0378ASUC-0379ASUD-0067ASUD-0068ASUD-0088ASUD-0089ASUD-0091ASUD-0092ASUD-0093ASUD-0094ASUD-0095ASUD-0096ASUD-0097ASUD-0112ASUD-0113ASUD-0114ASUD-0115ASUD-0116ASUD-0117ASUD-0118ASUD-0119ASUD-0120ASUD-0121ASUD-0122ASUD-0160ASUD-0166
What the firm is doing
On 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.
DistributionShow detailsHide
Devices 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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2617-2025
- FDA 510(k) clearance · K230931The device's official FDA premarket clearance record
- FDA device classification · BSZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5160The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Draeger, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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