Class II
Medical Device Recall: Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Draegerwerk Ag & Co. Kgaa · November 17, 2023
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.
Distribution
No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.
States Affected
IN
Quantity Affected
50 imported to US, not distributed to end users
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0971-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.