Z-0727-03

ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed...

Name: Z-0727-03 ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2003-02-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-02-10 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 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... on 2003-02-10. The reason FDA records is "ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0727-03
Status: Terminated
Initiated: 2003-02-10
Posted: 2003-04-16
Terminated: 2005-01-19
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: JWM System, Tomographic, Nuclear
Reason for recall: ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.
Root cause tag: software
FDA root cause: Other
Action: 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.
Quantity in commerce: 600 units
Distribution: 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.
Product codes and lots: 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.

Product code JWM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)