Recall Z-0971-2024 · BSZ Gas-Machine, Anesthesia
Draegerwerk Ag & Co. Kgaa
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
| Date | Feb 1, 2024 (initiated Nov 17, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230931 | Atlan Drägerwerk AG Co. Kgaa, Jul 23, 2023 |