Company: Siemens Medical Systems, Inc
Date of Enforcement Report: 10/24/01
Class: III
RECALL NUMBER, PRODUCT AND CODE:
Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed
in E.CAM Emission Imaging Computed Tomography Systems used for all common
nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Codes: MECC Backplane “2104938 REV C” — a component in the following cameras
a) Model 4380221 – E.CAM Gantry Dual Head, serial numbers 00005, 01007A, 01008A, 01141, 01181 through 01215
b) Model 5242826 – E.CAM Gantry Dual Head, serial numbers 01001 through 01075
c) Model 4380213 – E.CAM Gantry Single Head, serial numbers 01002 through 01014
REASON:
Backplane traces become overheated, causing CT camera to becomeinoperable
MANUFACTURER/RECALLING FIRM:
Siemens Medical Systems, Inc., Hoffman Estates, IL
RECALLED BY:
Recalling firm issued Service Bulletin on 4/11/00.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide and Worldwide
QUANTITY:
111 units