Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification, which per the severity rubric indicates potential for serious patient health hazards or death. Mechanical ventilator failure during anesthesia poses critical risk to patient safety.
Plain-English summary
The FDA is recalling the Atlan A350 anesthesia workstation manufactured by Draeger Medical, Inc. (Model 8211500) due to failures of the piston ventilator system. The ventilator either failed during pre-use checks or during active patient care.
Approximately 1,492 units of the Atlan A350 have been distributed, with 139 units in the United States across 21 states and 1,353 units internationally in 59 countries. Specific affected serial numbers are listed in the recall notice.
Piston ventilator failure during surgery poses a critical patient safety risk. The FDA classified this as a Class I recall, indicating potential for serious health consequences.
If you own or operate an Atlan A350 anesthesia workstation, verify that your unit's serial number is not on the recall list. Contact Draeger Medical for service bulletins, replacement units, or further instructions.
The recalled product
- Product
- Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- ventilator-failure
- mechanical-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Catalog Number: 8211500
- UDI-DI Number: 04048675556176
- Serial Numbers Distributed in the US: ASTB-0038
- 0039
- 0146
- 0147
- 0148
- 0281
- 0282
- 0283
- 0300
- 0301
- 0302
- 0303
- 0312
- 0313
- 0314
- 0315
- 0316 ASTC-0005
- 0094
Distribution
Distributed nationwide across the United States.
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