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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Artis with Laird Cooling Unit for SSFD

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  Class 2 Device Recall AXIOM Artis with Laird Cooling Unit for SSFD see related information
Date Initiated by Firm May 25, 2018
Create Date July 20, 2018
Recall Status1 Terminated 3 on May 16, 2019
Recall Number Z-2525-2018
Recall Event ID 80476
510(K)Number K021021  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Code Information Laird Cooling Unit for SSFD: Material # 7555118.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
FDA Determined
Cause 2		 Process control
Action Siemens issued on May 25, 2018 an URGENT: MEDICAL DEVICE CORRECTION customer notification to affected customers and advised a hardware update will be initiated . Users advised of the problem, potential risks and action to be taken. Siemens will correct the error by replacing all affected cooling units with Update Instruction AX076/17/S. Users may continue to use the Artis system while awaiting implementation of the corrective action.
Quantity in Commerce 6 units US
Distribution HI , IL, MI, NC, NY, VA, WI
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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