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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Uroskop

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 Class 2 Device Recall Siemens Uroskopsee related information
Date Initiated by FirmNovember 27, 2002
Date PostedJanuary 30, 2003
Recall Status1 Terminated 3 on January 10, 2005
Recall NumberZ-0493-03
Recall Event ID 25329
510(K)NumberK923049 
Product Classification Table, Radiographic, Tilting - Product Code IXR
ProductUroskop D1/D2/D3 - Table, Radiographic, Stationary Top.
Code Information Uroskop D1 -- Model #9785023 Uroskop D2/D3 -- Model #9785015
Recalling Firm/
Manufacturer
Siemens Medical Systems Inc
186 Wood Ave So
Iselin NJ 08830
For Additional Information ContactRoland Richter
732-321-4835
Manufacturer Reason
for Recall
There is unintended system movement or unwanted automatic movement of the tabletop.
FDA Determined
Cause 2
Other
ActionSiemens personal will install Host Software VA00F and Generator Host Software VE00D on affected Uroskop units. Update instructions were sent to users November 27,2002 and December 7, 2002.
Quantity in Commerce13
DistributionProduct was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were distributed to Germany, Netherlands, Italy , Luxembourg, Sweden, Austria, Switzerland, Slovakia, Hungary, Ukraine, Russia, Turkmenistan, South Africa, Canada, Malaysia, Japan, and Taiwan.
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 = IXR
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