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 Leonardo Workstation

  • 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 Leonardo Workstation see related information
Date Initiated by Firm December 21, 2007
Date Posted April 29, 2008
Recall Status1 Terminated 3 on September 30, 2008
Recall Number Z-1038-2008
Recall Event ID 46360
510(K)Number K040970  
Product Classification x-ray image archiving system - Product Code LLZ
Product Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
Code Information Model Number: 7129534. Serial Numbers: 10483, 10651, 10628, 10488, 10605, 10676, 10658, 10421, 10685, 10724, 10584, 10619, 10626, 10629, 10635, 10694, 10706, 10438, 10600, 10668, 10655, 10436, 10606, 10702, 10433, 10558, 10636, 10642, 10692, 10698, 10412, 10440, 10539, 10613, 10674, 10621, 10634, 10583, 10684, 10476, 10414, 10664, 10671, 10712, 10472, 10567, and 10641. Software version VB30B.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Cathrine Moffa
610-448-1774
Manufacturer Reason
for Recall		 Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.
Quantity in Commerce 47 Units
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 = LLZ and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
-
-