FDA DevicesClass I
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Published: June 10, 2026Recall ID: Z-2208-2026Category: devicesCountry: US
Reason for Recall / Hazard
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Product Description & Identification
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Affected Products
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Additional Source Details
| Field | Value |
|---|---|
| City | Telford |
| State | PA |
| Event id | 98914 |
| Address 1 | 3135 Quarry Rd |
| Code info | Model Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354, ASSL-0357, ASSL-0360, ASSH-0240, ASSH-0242, ASSH-0243, ASSH-0245, ASSH-0246, ASSH-0247, ASSH-0248, ASSH-0249, ASSH-0250, ASSL-0355, ASSL-0356, ASSL-0358, ASSL-0359, ASSL-0361, ASSH-0239, ASSH-0241, ASSH-0244, ASSH-0251, ASSH-0252, ASSH-0253, ASSH-0254, ASTA-0308, ASTA-0310, ASTA-0312, ASTA-0271, ASTA-0272, ASTA-0273, ASTA-0274, ASTA-0275, ASTA-0276, ASTA-0352, ASTA-0354, ASTA-0364, ASTA-0395, ASTA-0396, ASTA-0397, ASTA-0407, ASSM-0464, ASSM-0465, ASSM-0466, ASSM-0467, ASSM-0468, ASSM-0469, ASSM-0491, ASSM-0492, ASSM-0493, ASSM-0494, ASSM-0495. |
| Postal code | 18969-1042 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 394 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260507 |
| Initial firm notification | |
| Center classification date | 20260604 |
Overview
- Recalling FirmDraeger, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS 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