Recall Z-0727-03 ยท JWM System, Tomographic, Nuclear
Siemens Medical Solutions USA, Inc.
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
| Date | Apr 16, 2003 (initiated Feb 10, 2003) |
| Status | Terminated |
| Reason | ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions. |
| 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 |
| Quantity | 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 Zeal |
| FDA record | Open on fda.gov |