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 Leonard MMWS

  • 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 Leonard MMWS see related information
Date Initiated by Firm September 28, 2004
Date Posted November 03, 2004
Recall Status1 Terminated 3 on September 04, 2008
Recall Number Z-0163-05
Recall Event ID 30173
510(K)Number K010938  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534
Code Information Serial Numbers: 6026, 6037, 6047, 6106, 6114, 6115, 6116, and 20014
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter,
610-448-1777
Manufacturer Reason
for Recall		 Calcium Scoring feature on this devices is not closing properly after patient's exams.
FDA Determined
Cause 2		 Other
Action The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
Quantity in Commerce 8 units
Distribution The product was shipped to medical facilities nationwide and government account in IL.
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 = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
-
-