24

Oct

2001

Inc Class III Siemens Medical Systems

0

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

About the author

Amy Sellers

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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