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Terminated

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 Recall Z-0727-03 · Posted 2003-04-16

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeJWM
Date Initiated2003-02-10
Date Terminated2005-01-19
Product Quantity600 units

Reason for Recall

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

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K914350ICON COMPUTER SYSTEMSiemens Gammasonics, Inc. · 1991-11-22K903315ICONSiemens Gammasonics, Inc. · 1991-01-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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