Date Initiated by Firm | May 25, 2018 |
Create Date | July 20, 2018 |
Recall Status1 |
Terminated 3 on May 16, 2019 |
Recall Number | Z-2526-2018 |
Recall Event ID |
80476 |
510(K)Number | K141574 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Artis zee systems 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
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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 | 3 US |
Distribution | HI , IL, MI, NC, NY, VA, WI |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = OWB
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