Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Reported: November 20, 2024 Initiated: October 15, 2024 #Z-0304-2025
Product Description
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
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.
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 1,492 units (139 units US, 1,353 OUS)
- Distribution
- 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.
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable. Recalled by Draeger Medical, Inc.. Units affected: 1,492 units (139 units US, 1,353 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2024. Severity: Critical. Recall number: Z-0304-2025.
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