Atlan, Gas Machine for Anesthesia or Analgesia, Catalog… recallZ-0971-2024 · Draegerwerk Ag & Co. Kgaa · initiated Nov 17, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draegerwerk Ag & Co. Kgaa or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-0971-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 17, 2023
- Posted by the FDA
- Feb 1, 2024
- Recalling firm
- Draegerwerk Ag & Co. Kgaa
- Quantity
- 50 imported to US, not distributed to end users
- Product code
- BSZ
- FDA submissions
- K230931
- Distribution
- No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.
Product description
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Atlan A350 8621500Drägerwerk AG & Co. KGaA · Gas-Machine, Anesthesia4 recalls63 reports
- Atlan A350 XL 8621600Drägerwerk AG & Co. KGaA · Gas-Machine, Anesthesia4 recalls1 death14 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page