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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee/zeego system, xray, angiographic

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  Class 2 Device Recall Artis zee/zeego system, xray, angiographic see related information
Date Initiated by Firm February 26, 2016
Date Posted March 31, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-1299-2016
Recall Event ID 73548
510(K)Number K073290  
Product Classification System, x-ray, angiographic - Product Code IZI
Product system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959

Artis zee/ zeego 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.
Code Information Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-6461
Manufacturer Reason
for Recall		 In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.
FDA Determined
Cause 2		 Device Design
Action The firm, Siemens, sent an "Important Customer Safety Notice" dated 2/16/2016 to its customers. The notice informed them of a corrective action that will be performed to prevent a possible hazard to patients, operators, other persons or equipment. The notice described the product, problem and actions to be taken. Siemens plans to contact each customer to arrange a date to add additional protection mechanisms by means of a system software update. If you have any questions, contact Engineer, Regulatory Technical Specialist at 610-448-6461 or email: Meredith.adams@siemens.com.
Quantity in Commerce 552 units
Distribution US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and PUERTO RICO.
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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