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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis U

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  Class 2 Device Recall Axiom Artis U see related information
Date Initiated by Firm June 29, 2011
Date Posted August 11, 2011
Recall Status1 Terminated 3 on January 24, 2014
Recall Number Z-3009-2011
Recall Event ID 59275
510(K)Number K040675  
Product Classification System, x-ray, mobile - Product Code IZL
Product Siemens Axiom Artis U mobile x-ray system

Product Usage: Mobile x-ray system
Code Information Model number 10094012; serial numbers 20202, 20223, 20231, 20422, 20402, 20435, 21022, 22002, 21005, and 20432.   Model number 7008530; serial numbers 20146, 21112, 20003, 20115, 20135, 20006, 20113, and 20120.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-448-3237
Manufacturer Reason
for Recall		 When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240:
FDA Determined
Cause 2		 Labeling False and Misleading
Action Siemens sent a "Customer Safety Advisory Notice" letters to all affected users dated June 13, 2011. The letter identified the product, the problem, and the actions to be taken. Siemens included in the notice an addendum to the instruction for use to each system and request customers to take special attention. Customers were instructed to place the Safety Notice in the System's instruction for use. All appropriate personnel should be notified of the correction notice. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner.
Quantity in Commerce 18
Distribution Nationwide Distribution (USA) including the states of: CA, CT, FL, KS, MN, MO, NJ, NY, NC, PA, and UT.
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 = IZL and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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