Anesthesia workstation piston ventilator may fail before or during use
Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical 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: This recall is classified FDA Class I, which mandates a minimum severity score of 4 per the rubric. Although no illnesses or injuries are reported, mechanical failure of ventilator function in a critical anesthesia device presents serious risk during patient care.
Plain-English summary
Draeger Medical, Inc. is recalling 455 units of the Atlan A350XL anesthesia workstation (310 in the US, 145 internationally) due to mechanical failure of the piston ventilator.
The affected devices may either indicate ventilator failure before use or experience ventilator failure during mechanical ventilation. This defect prevents or impairs the device's ability to deliver mechanical ventilation during anesthesia procedures.
The recalled units are distributed across multiple US states and more than 50 countries worldwide. The FDA has identified specific serial numbers for affected units in both domestic and international distributions.
The recalled product
- Product
- Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 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: 8621600
- UDI-DI Number: 04048675556183
- Serial Numbers Distributed in the US: ASTA-0307
- 0309
- 0311
- 0349
- 0350
- 0351
- 0353
- 0363
- 0365
- 0394
- 0408
- 0409 ASTB-0048
- 0286
- 0287
- 0288
- 0289
- 0290
- 0291
Distribution
Distributed nationwide across the United States.
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