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
|
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
|
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.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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