FDA Medical Device Recalls (openFDA)
Draegerwerk Ag & Co. Kgaa: Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
- Recall number
- Z-0971-2024
- Recalling firm
- Draegerwerk Ag & Co. Kgaa
- Product
- Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
- Status
- Open, Classified
- Initiated
- 2023-11-17
- Posted
- 2024-02-01
- Terminated
- not on file
- Reason
- Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.
- Root cause
- Use error
- Action
- Draeger US was notified of the recall by their corporate office in Germany on November 17, 2023. All 50 units imported into the US at the time had not been distributed to end-users and were under the direct control of Draeger, Inc. Therefore, the firm did not issue a recall communication to customers. As a corrective action, an Instructions for Use (IFU) supplement has been added to these affected devices. The supplement outlines additional instructions regarding battery operation and inspection. Future shipments of Atlan devices will have the IFU supplement included with the device shipment.
- Quantity
- 50 imported to US, not distributed to end users
- Distribution
- No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.
- Lot, serial or model codes
- UDI-DI: 04048675556176 (Atlan A350) 04048675556183 (Atlan A350 XL) Lots: ASSH-0220 ASSH-0221 ASSH-0222 ASSH-0223 ASSH-0224 ASSH-0225 ASSH-0226 ASSH-0227 ASSH-0228 ASSH-0229 ASSH-0230 ASSH-0231 ASSH-0232 ASSH-0233 ASSH-0234 ASSH-0235 ASSH-0236 ASSH-0237 ASSH-0238 ASSH-0239 ASSH-0240 ASSH-0241 ASSH-0242 ASSH-0243 ASSH-0244 ASSH-0245 ASSH-0246 ASSH-0247 ASSH-0248 ASSH-0249 ASSH-0250 ASSH-0251 ASSH-0252 ASSH-0253 ASSH-0254 ASSL-0347 ASSL-0347 ASSL-0349 ASSL-0350 ASSL-0351 ASSL-0352 ASSL-0353 ASSL-0354 ASSL-0355 ASSL-0356 ASSL-0357 ASSL-0358 ASSL-0359 ASSL-0360 ASSL-0361
- 510(k) numbers
- ["K230931"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 3001104093
- Firm city
- Lubeck
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28