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U.S. Department of Health and Human Services

Class 3 Device Recall Leonardo Workstations with software version 2022A/B, 2003A

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 Class 3 Device Recall Leonardo Workstations with software version 2022A/B, 2003Asee related information
Date Initiated by FirmFebruary 28, 2003
Date PostedAugust 07, 2003
Recall Status1 Terminated 3 on December 23, 2004
Recall NumberZ-1088-03
Recall Event ID 26218
510(K)NumberK010938 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductLeonardo Workstations with software version 2022A/B, 2003A
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 ContactRoland 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
ActionThe 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 Commerce1374 units
DistributionThe product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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