FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.
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: This FDA Class I recall meets the minimum Severe (4) classification per the rubric, which specifies never to go below 4 for FDA Class I. No reported injuries or fatalities are mentioned in the source material, preventing escalation to Critical (5).
Plain-English summary
Draeger Medical, Inc. has recalled 25 units of the Atlan A300XL anesthesia workstation (Model 8621400) due to potential piston ventilator failure. The device may either indicate a failure before use or fail to maintain mechanical ventilation during use.
The Atlan A300XL is an anesthesia workstation intended for anesthetizing adults, pediatrics, and neonates. All 25 recalled units were distributed outside the United States, with shipments to multiple countries in Europe, Asia, the Middle East, Africa, and the Americas. No devices were imported into or distributed within the United States.
The recalled devices may exhibit ventilator failure either as a detectable malfunction before use or as a loss of mechanical ventilation capability during anesthesia delivery. The FDA has classified this as a Class I recall.
The recalled product
- Product
- 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.
- 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: 8621400
- UDI-DI Number: 04048675556343
- Serial Numbers shipped directly from Draegerwerk AG & Co.
- KGaA to OUS: ASTB-0051
- 0053
- 0054
- 0055
- 0063
- 0065
- 0093
- 0162 ASTE-0219
- 0220
- 0221
- 0222
- 0377 ASTF-0472
- 0473 ASTH-0005
- 0006
- 0026
- 0027
- 0047
Distribution
Distribution scope not specified by the agency.
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