Company: SIEMENS MEDICAL SYSTEMS, INC
Date of Enforcement Report: 9/19/01
Class: II
RECALL NUMBER, PRODUCT AND CODE:
Z-1106-1 – Z-1108-1
Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures;
Codes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 through 2016
b) Model 4380221 – E.CAM Gantry Dual Head, serial numbers 0005 through 2038, and 31827
c) Model 5242826 – E.CAM Gantry Dual Head,serial numbers 1001 through 2012
REASON:
Resistor Packs installed backward causes software errors.
MANUFACTURER/RECALLING FIRM:
SIEMENS MEDICAL SYSTEMS, INC. HOFFMAN ESTATES, IL
RECALLED BY:
Recalling Firm, by visit on 12/4/98. No end user notifications were issued.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide and worldwide
QUANTITY:
229 units