| Class 2 Device Recall Artis zee angiographic xray system |  |
Date Initiated by Firm | February 03, 2017 |
Create Date | July 14, 2017 |
Recall Status1 |
Terminated 3 on October 24, 2017 |
Recall Number | Z-2686-2017 |
Recall Event ID |
77201 |
510(K)Number | K073290 |
Product Classification |
System, x-ray, angiographic - Product Code IZI
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Product | Artis zee,x-ray system, angiographic
Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis |
Code Information |
Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | 610-219-4834 |
Manufacturer Reason for Recall | Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit. |
FDA Determined Cause 2 | Component design/selection |
Action | CDRH approved the CAP subject to the following conditions:
1. You completed this recall as of May 6, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator.
2. If this recall is expanded to include any additional consignees, models, or end users, any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. |
Quantity in Commerce | 97 distributed worldwide, 12 distributed in United States |
Distribution | Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY |
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 = IZI
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