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U.S. Department of Health and Human Services

Class 3 Device Recall ICON 9.5 Software

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 Class 3 Device Recall ICON 9.5 Softwaresee related information
Date Initiated by FirmFebruary 10, 2003
Date PostedApril 16, 2003
Recall Status1 Terminated 3 on January 19, 2005
Recall NumberZ-0727-03
Recall Event ID 25541
510(K)NumberK903315 K914350 
Product Classification System, Tomographic, Nuclear - Product Code JWM
ProductICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
Code Information All Diacam, Multispect 2, Multispect 3 and e.cam camera systems with ICON workstations with ICON software version 9.5 and the optional Whole Body SPECT software.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates IL 60195-5203
For Additional Information ContactMr. Ron Nolte
847-304-7700
Manufacturer Reason
for Recall		ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.
FDA Determined
Cause 2		Other
ActionSiemens sent Customer Advisory letters dated 2/10/03 to all ICON 9.5 customers with Whole Body SPECT functionality on integrated camera systems including Diacam, Multispect 2, Multispect 3 and e.cam camera systems aquired on an ICON workstation. The accounts were informed of the problem related to applying the flood correction matrix to Whole Body SPECT studies in ICON version 9.5 software, and were provided the follwoing workaround: To ensure that the flood correction is applied, the user should acquire multiple single bed positions with the General SPECT predefine, indexing the bed manually between each SPECT acquisition. The data can then be combined into a Whole Body SPECT in the Whole Body SPECT Display program for review. In addition, users were requested to routinely perform standard quality control procedures at the facility to ensure proper image quality. No software upgrade is planned.
Quantity in Commerce600 units
DistributionNationwide, United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Equador, Egypt, France, Germany, Great Britain, Georgia, Greece, Hong Kong, Israel, India, Italy, Jordan, Japan, Korea, Latvia, Mexico, Niger, Norway, New Zealand, Philippines, Pakistan, Poland, Russia, Saudi Arabia, SIngapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine and the Netherlands.
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 = JWM
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