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Brand Name: Atlan recallZ-0668-2025 · Draeger Medical, Inc. · initiated Oct 15, 2024

Class I Open, Classified All recalls posted in December 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

FDA root cause category: Process control

What the company is doing

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. Please ensure that all users of the Draeger Atlan as well as other persons concerned within your organization are made aware of this Urgent Medical Device Correction notice. Complete and return the 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 8AM-8PM EST at 1-800-437-2437 (press 2, then 2, then 2 again). Questions regarding this Urgent Medical Device Correction notice, contact Michael Kelhart 8AM-4:30PM EST at 267-664-1131 or via email at [email protected].

Recall details

Recall number
Z-0668-2025
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Oct 15, 2024
Posted by the FDA
Dec 18, 2024
Recalling firm
Draeger Medical, Inc.
Quantity
25 units (OUS Only)
Product code
BSZ
FDA submissions
K230931
Distribution
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.

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.

Code information (models, lots, serial numbers)

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 devices under the same FDA submission

2 devices cleared under K230931 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95759).

Sources and updates

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