Atlan A350XL anesthesia workstations may fail during mechanical ventilation
Atlan A350XL anesthesia workstations are being recalled because units either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.
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 recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Atlan A350XL anesthesia workstation, model number 8621600, UDI-DI 04048675556183, is being recalled. The action covers 394 units, identified by the serial numbers in the recall notice.
The stated reason is that the Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. The FDA classified the action as Class I, its most serious classification.
Distribution was within the United States, in Wisconsin, Arkansas, Minnesota, Colorado, Massachusetts, Pennsylvania, Arizona, Florida, New York, South Dakota and North Dakota, and internationally. The workstations are installed in hospital operating rooms rather than sold to consumers.
Facilities should identify affected units using the model number, UDI-DI and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Atlan A350XL. Model Number: 8621600. anesthesia workstation
- Manufacturer
- Draeger, Inc.
- Affected units
- 394
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 Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354
- ASSL-0357
- ASSL-0360
- ASSH-0240
- ASSH-0242
- ASSH-0243
- ASSH-0245
- ASSH-0246
- ASSH-0247
- ASSH-0248
- ASSH-0249
- ASSH-0250
- ASSL-0355
- ASSL-0356
- ASSL-0358
- ASSL-0359
- ASSL-0361
- ASSH-0239
- ASSH-0241
- ASSH-0244
Distribution
Part of a larger recall action
This product is one of 2 recalled by Draeger, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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