Company: SIEMENS MEDICAL SYSTEMS, INC.
Date of Enforcement Report: 9/12/01
Class: II
RECALL NUMBER, PRODUCT AND CODE:
Z-1105-1/Z-1107-1
Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine proceduresCodes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 thru 2016
b) Model 4380221 – E.CAM Gantry Dual Head, serial numbers 0005 thru 2038,
and 31827 Model 5242826 – E.CAM Gantry Dual Head, serial numbers 1001 thru
2012
REASON:
Resistor Packs installed backwards cause software errors
MANUFACTURER/RECALLING FIRM:
SIEMENS MEDICAL SYSTEMS, INC. HOFFMAN ESTATES, IL
RECALLED BY:
No end user notifications were issued. Siemens initiated a Mandatory Next Service Call Field Modification Instruction (FMI-00270) on 12/4/98
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide and International
QUANTITY:
229 units
