—#26005

Product

ICON 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

FDA product code: JWM — System, Tomographic, Nuclear
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K903315, K914350
Affected lot / code info: 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.

Why it was recalled

ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.

Root cause (FDA determination)

Other

Action the firm took

Siemens 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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 N. Barrington Road, Hoffman Estates, Illinois 60195-5203

Distribution

Distribution pattern: Nationwide, 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.

Timeline

Recall initiated: 2003-02-10
Posted by FDA: 2003-04-16
Terminated: 2005-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.