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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis zee systems

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 Class 2 Recall
Siemens Artis zee systems
see related information
Date Posted November 14, 2013
Recall Status1 Open
Recall Number Z-0172-2014
Recall Event ID 65795
Premarket Notification
510(K) Number
K090745 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Artis zee systems x-ray, angiographic system
Code Information model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Siemens Customer Service
610-219-6300
Manufacturer Reason
for Recall
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
FDA Determined
Cause 2
DESIGN: Device Design
Action Siemens sent an letter to all affected customers in January 2013, notifying them of the potential issue and urging customers to make appointments with Siemens to have software update AX 027/12/S realized in order to resolve the problem. The software update was made available from January 22, 2013, on. Customers were also asked to pass along this information if the device was no longer in their possession. The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 17 unit(s) will consist of the following: 1. The firm sent out a customer notification letter in January 2013 notifying them of the issue and highlighting the approved procedures of the Corrective Action Plan. 2. Siemens directed in the customer notification letter, for the end-user to make an appointment with the Customer Service organization to have safety update AX 027/12/S realized. 3. As stated in the safety update AX 027/12/S and in the e-mail response the update to correct this issue will be provided to the customer at no expense. 4. Siemens indicated in the customer notification letter that the AX 027/12/S update will be made available from January 22, 2013 and on. 5. The AX 027/12/S update provides general information, work instructions and a completion certificate on how to correct the dislocated scatter radiation filter inside the collimator. You may proceed with implementation of the CAP (subject to the conditions noted above). For further questions please call (610) 219-6300.
Quantity in Commerce 17
Distribution US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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