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U.S. Department of Health and Human Services

Class 2 Device Recall Somatom

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 Class 2 Device Recall Somatomsee related information
Date Initiated by FirmOctober 11, 2002
Date PostedMay 16, 2003
Recall Status1 Terminated 3 on October 03, 2006
Recall NumberZ-0842-03
Recall Event ID 26082
510(K)NumberK013522 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
ProductSomatom Sensation 16, Computed Tomography System, Diagnostic Imaging.
Code Information Model Number 7393114
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
Perfusion CT is displaying a higher gray and color values than normal. A software problem.
FDA Determined
Cause 2
Other
ActionUpdate 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 Commerce1
DistributionThe 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 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 = KPS
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