Compnay: Siemens Medical Systems, Inc
Date of Enforcement Report: 9/12/01
Class: II
RECALL NUMBER, PRODUCT AND CODE:
Z-0851-1
ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203. Codes: All E.CAM gamma cameras with the Profile option with ICON-P workstations and ICON software revision 8.1 or greater
REASON:
Artifacts on images from profile scans
MANUFACTURER/RECALLING FIRM:
Siemens Medical Systems, Inc., Hoffman Estates, IL
RECALLED BY:
Manufacturer, There was no end user notification other than the statement “Please install ICON 8.5 (Rev. 02) software on all ICON P workstations which processProfile studies.”, which was included in the “What’s New for ICON 8.5” letter
sent to ICON Users that was revised in February 2000.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
National and International
QUANTITY:
125 units
