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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Artis

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  Class 2 Device Recall AXIOM Artis see related information
Date Initiated by Firm January 05, 2018
Date Posted March 20, 2018
Recall Status1 Terminated 3 on August 23, 2018
Recall Number Z-1150-2018
Recall Event ID 79540
510(K)Number K021021  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392

AXIOM Artis 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 Serial Numbers: 35061 35054 34999 35098 35059 35064 35073 35071 35057 35075 35083 35018 35097 35108 35046 35048 35050 46004 35045 35004 44011 35095 
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		 Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
FDA Determined
Cause 2		 Process control
Action The firm, Siemens Healthineers, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 1/5/2018 to its consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to follow their standard emergency procedures in place in the event of system failures; to consider reinforcing these emergency procedures until the update has been completed. Siemens will replace all affected plastic couplings with metal couplings. The Siemens service organization will contact the consignees to arrange a date to perform this corrective action.If the device has been sold and is therefore no longer in your possession, please forward this field correction notice to the new owner. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce 22
Distribution US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
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 = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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