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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm June 05, 2014
Date Posted September 22, 2014
Recall Status1 Terminated 3 on April 21, 2015
Recall Number Z-2569-2014
Recall Event ID 68704
510(K)Number K073290  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Artis zee and Artis zeego systems.

x-ray, angiographic system
Code Information running software version VC21B   10094135, 10094137, 10094141, 10280959 with multiple serial numbers .
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.
FDA Determined
Cause 2		 Software design
Action Siemens sent an "Important Customer Safety Notice" dated August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please forward this Safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this safety notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this Customer Safety Notice and comply with the corresponding measures until the update has been fully completed. For further questions please call (610) 219-6300.
Quantity in Commerce 206
Distribution Nationwide Distribution
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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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