Company: Siemens Medical Systems, Inc.
Date of Enforcement Report: 9/5/01
Class: II
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
CODES:
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.
REASON:
Incorrect orientation of acquired patient data
MANUFACTURER/RECALLING FIRM:
Siemens Medical Systems, Inc. Hoffman Estates, IL.
RECALLED BY:
Manufacturer, by letter on 5/30/01.
FIRM INITIATED RECALL:
Ongoing.
DISTRIBUTION:
Nationwide and Argentina, Brazil, Canada, China, Germany, Spain, Great Britain, Japan, Sweden, Turkey, Austria, Switzerland, Korea, Taiwan and the Netherlands.
QUANTITY:
109 units.
