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U.S. Department of Health and Human Services

Class 2 Device Recall Leonardo

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  Class 2 Device Recall Leonardo see related information
Date Initiated by Firm October 11, 2002
Date Posted May 16, 2003
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-0841-03
Recall Event ID 26082
510(K)Number K010938  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Leonardo MM-WS systems. System, Image Processing.
Code Information Model Number 7129534
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		 Perfusion CT is displaying a higher gray and color values than normal. A software problem.
FDA Determined
Cause 2		 Other
Action Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.
Quantity in Commerce 2
Distribution The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO.
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.
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