Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall The Ysio Systems with software version VC10

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall The Ysio Systems with software version VC10 see related information
Date Initiated by Firm August 27, 2014
Date Posted September 23, 2014
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-2680-2014
Recall Event ID 69148
510(K)Number K081722  
Product Classification System, x-ray, stationary - Product Code KPR
Product The Ysio Systems with software version VC10

The Ysio 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.
Code Information Model numbers: 10281013, 10281163.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Siemens, sent a "Safety Advisory Notice" dated August 27, 2014, to end users/customers. The notice identified the product, problem, and action to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization who have to be aware of this problem; forward this safety information to other organizations affected by this measure; and if the device has been sold and therefore no longer in your possession, forward to new owner. Siemens prepared a field modification of the Ysio systems with a hardware upgrade. This field modification will be available in September 2014. If you have any questions, please contact Regulatory Specialist at 610-219-4334 or Customer support at 610-219-6300.
Quantity in Commerce 62
Distribution Nationwide Distribution.
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.
-
-