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Open, Classified

Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

FDA Recall Z-0971-2024 · Posted 2024-02-01

Recalling FirmDraegerwerk Ag & Co. Kgaa
Recall StatusOpen, Classified
Product CodeBSZ
Date Initiated2023-11-17
Product Quantity50 imported to US, not distributed to end users

Reason for Recall

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.

Firm 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.

Root Cause

Use error

Distribution Pattern

No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K230931AtlanDrägerwerk AG Co. Kgaa · 2023-07-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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