Recall Z-0971-2024— Draegerwerk Ag & Co. Kgaa
Class II · Ongoing
Class II FDA medical device recall by Draegerwerk Ag & Co. Kgaa, initiated 2023-11-17. It names one FDA 510(k) clearance: K230931. Product: Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL). 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..
- Recalling firm
- Draegerwerk Ag & Co. Kgaa
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-17
- Firm location
- Lubeck, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.