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Class 2 Device Recall Axiom Artis Zee Multipurpose |
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Date Initiated by Firm |
October 26, 2009 |
Date Posted |
December 03, 2009 |
Recall Status1 |
Terminated 3 on January 26, 2010 |
Recall Number |
Z-0485-2010 |
Recall Event ID |
53844 |
510(K)Number |
K073290
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Product Classification |
Angiographic x-ray system - Product Code IZI
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Product |
Axiom Artis Zee Multi-purpose, Model number 10094139
angiographic x-ray systems |
Code Information |
Serial numbers: 157136, 157139, 157146, 157156, 157164, 157165, 157168, 157169, 157184, 157213, and 157215. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact |
Meredith Adams 610-219-6300
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Manufacturer Reason for Recall |
c-arm may tilt
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FDA Determined Cause 2 |
Other |
Action |
The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons. |
Quantity in Commerce |
11 units |
Distribution |
Nationwide |
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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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