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U.S. Department of Health and Human Services

Class 2 Device Recall Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license

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  Class 2 Device Recall Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license see related information
Date Initiated by Firm December 15, 2014
Date Posted January 16, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-0994-2015
Recall Event ID 70020
510(K)Number K133259  K062623  K111292  
Product Classification System, x-ray, stationary - Product Code KPR
Product Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license.

The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Code Information Material 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470  serial numbers24077 24051 24038 24059 24066 24015 24026 24058 24039 24090 24075 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
FDA Determined
Cause 2		 Software design
Action The firm, Siemens, sent a "Safety Advisory Notice - XP080/14/S" letter dated December 8, 2014, to end users that identified the product, problem, and actions to be taken. Siemens provided instructions to avoid the issue and indicated a software fix would be released as a permanent resolution. The customers were instructed observe this safety notice and comply with the corresponding measure until the update has been fully completed. If you have any questions, contact the Regulatory Technical Specialist at 610-219-2119.
Quantity in Commerce 11
Distribution US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.
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 = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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