[pending] Atlan A350XL. Model Number: 8621600. anesthesia workstation
Pending LLM rewrite. Source: FDA_DEVICE Z-2208-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Atlan A350XL. Model Number: 8621600. anesthesia workstation
- Manufacturer
- Draeger, Inc.
- Category
- Medical Device — Devices
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
Distributed in 11 states:
- AR
- AZ
- CO
- FL
- MA
- MN
- ND
- NY
- PA
- SD
- WI
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