INC.Class II SIEMENS MEDICAL SYSTEMS

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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