FDA Medical Device Recalls (openFDA)
Draeger, Inc.: Atlan A350. Model Number: 8211500. anesthesia workstation
- Recall number
- Z-2207-2026
- Recalling firm
- Draeger, Inc.
- Product
- Atlan A350. Model Number: 8211500. anesthesia workstation
- Status
- Open, Classified
- Initiated
- 2026-05-07
- Posted
- 2026-06-04
- Terminated
- not on file
- Reason
- 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
- Process change control
- Action
- Draeger notified consignees of the recall update and expansion on about 05/07/2026 via emailed letter titled Urgent Medical Device Correction Update. Consignees were made aware that due to continuous monitoring, Draeger has determined that an additional number of Atlan devices are affected by the issue and they are replacing ventilator motors. Consignees were instructed that a Draeger Service Representative will contact consignees to arrange a date for the ventilator motor assembly replacement, and until the corrective action is implemented, the device may continue to be used 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. Consignees were also instructed to complete and return the provided Medical Device Correction Return Response Acknowledgment and Receipt Form and if products have been made available to third parties, please forward this Urgent Medical Device Correction notice to them.
- Quantity
- 3,515 units
- Distribution
- US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Lot, serial or model codes
- Model Number: 8211500. UDI-DI Number: 04048675556176.Serial Numbers: ASSL-0347, ASSL-0348, ASSL-0351, ASSH-0220, ASSH-0221, ASSH-0224, ASSH-0225, ASSH-0228, ASSH-0229, ASSH-0230, ASSH-0234, ASSH-0235, ASTA-0086, ASSL-0349, ASSL-0350, ASSL-0352, ASSL-0353, ASSH-0222, ASSH-0223, ASSH-0226, ASSH-0227, ASSH-0231, ASSH-0232, ASSH-0233, ASSH-0236, ASSH-0237, ASSH-0238, ASSN-0185, ASSN-0186, ASSN-0187, ASSN-0188, ASSN-0189, ASSN-0190, ASTB-0037, ASTB-0040, ASTA-0087, ASTA-0088, ASSM-0130, ASSM-0131, ASSM-0132.
- 510(k) numbers
- ["K230931"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28