Draeger Medical, Inc.: Device Recall
Recall #Z-0305-2025 · 10/15/2024
Recall Details
- Recall Number
- Z-0305-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Draeger Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 10/15/2024
- Location
- Telford, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 455 units (310 units US, 145 OUS)
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.
Product Description
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, 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, Vietnam.
Other Recalls by Draeger Medical, Inc.
- Class I: Dangerous 10/15/2024
- Class I: Dangerous 10/15/2024
- Class I: Dangerous 10/15/2024