Class 2 Device Recall Axiom Artis U

• Date Initiated by Firm: June 29, 2011
• Date Posted: August 11, 2011
• Recall Status: Terminated 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: 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