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 3 Device Recall Leonardo Workstations

  • 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 3 Device Recall Leonardo Workstations see related information
Date Initiated by Firm February 28, 2003
Date Posted August 07, 2003
Recall Status1 Terminated 3 on December 23, 2004
Recall Number Z-1089-03
Recall Event ID 26218
510(K)Number K010938  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Leonardo Workstations with software versions prior to 2022A
Code Information Model 7129534 Serial #01001 through 01380, 05001 through 05600, and 10001 through 10320
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Parkway
Malvern PA 19355
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
FDA Determined
Cause 2		 Other
Action The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.
Quantity in Commerce 1374 units
Distribution The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
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 SOLUTIONS USA, INC.
-
-