Company: Siemens Medical Systems, Inc.
Date of Enforcement Report: 9/5/01
RECALL NUMBER, PRODUCT AND CODE:
Z-0769-1 – Z-0771-1
E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and above
b) E.CAM Duet models with e.soft workstations, e.soft software versions 1.0 and above
c) E.CAM+ models with ICON workstations, ICON software versions 8.0 and above all serial numbers with Coincidence mode package installed.
Incorrect orientation of acquired patient data
Siemens Medical Systems, Inc. Hoffman Estates, IL.
Manufacturer, by letter on 5/30/01.
FIRM INITIATED RECALL:
Nationwide and Argentina, Brazil, Canada, China, Germany, Spain, Great Britain, Japan, Sweden, Turkey, Austria, Switzerland, Korea, Taiwan and the Netherlands.