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

FDA device recall Z-0727-03 · posted 2003-04-16 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

JWM

Quantity affected

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, Gre

Date initiated

2003-02-10

Date posted

2003-04-16

Date terminated

2005-01-19

Location

Hoffman Estates, IL

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