INC Class II SIEMENS MEDICAL SYSTEMS

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

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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