Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. While no deaths or reported injuries are documented in this notice, the hazard involves critical life-support equipment where ventilator failure creates serious risk of patient harm.
Plain-English summary
Draeger Medical, Inc. is recalling the Atlan A300 anesthesia workstation (Model 8211300, 280 units affected). The device's piston ventilator can either be detected as failed during pre-use checks, or can suffer mechanical ventilation failure during the anesthesia procedure itself.
Ventilator failures prevent proper patient ventilation during anesthesia, creating a critical patient safety risk. Anesthesia workstations are essential life-support equipment, and ventilator failure can result in inadequate oxygen delivery and serious anesthesia complications.
The affected devices were distributed to multiple countries outside the United States, including Argentina, Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, the United Kingdom, and Vietnam. Specific serial numbers with prefixes ASTA, ASTB, ASTC, ASTD, ASTE, ASTF, ASTH, and ASTK are affected.
Healthcare facilities using the Atlan A300 should immediately verify their device serial numbers against the recall list. Affected devices should not be used until corrective action is completed. Contact Draeger Medical, Inc. for further instructions.
The recalled product
- Product
- Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
- 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: 8211300
- UDI-DI Number: 04048675556343
- Serial Numbers shipped directly from Draegerwerk AG & Co.
- KGaA to OUS: ASTA-0314
- 0315
- 0325
- 0338
- 0340
- 0384
- 0411
- 0425 ASTB-0002
- 0010
- 0018
- 0151
- 0160
- 0161
- 0165
- 0175
- 0176
- 0177
Distribution
Distribution scope not specified by the agency.
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