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U.S. Department of Health and Human Services

Class 2 Device Recall Atlan

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  Class 2 Device Recall Atlan see related information
Date Initiated by Firm November 17, 2023
Date Posted February 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-0971-2024
Recall Event ID 93544
510(K)Number K230931  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and
8621600 (Atlan A350 XL)
Code Information 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
Recalling Firm/
Manufacturer		 Draegerwerk Ag & Co. Kgaa
Dragerwerk Ag & Co. Kgaa Accounts Payable
Moislinger Allee 53 -55
Lubeck Germany
For Additional Information Contact Michael A. Kelhart
267-6641131
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = Drägerwerk AG Co. KGaA
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