Draeger Medical, Inc.: Device Recall
Recall #Z-0668-2025 · 10/15/2024
Recall Details
- Recall Number
- Z-0668-2025
- 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
- 25 units (OUS Only)
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 A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Distribution Pattern
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.
Other Recalls by Draeger Medical, Inc.
- Class I: Dangerous 10/15/2024
- Class I: Dangerous 10/15/2024
- Class I: Dangerous 10/15/2024