05

Sep

2001

Inc. Class II Siemens Medical Systems

0

Company: Siemens Medical Systems, Inc.
Date of Enforcement Report: 9/5/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0769-1 – Z-0771-1
E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

CODES:
a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and above
b) E.CAM Duet models with e.soft workstations, e.soft software versions 1.0 and above
c) E.CAM+ models with ICON workstations, ICON software versions 8.0 and above all serial numbers with Coincidence mode package installed.

REASON:
Incorrect orientation of acquired patient data

MANUFACTURER/RECALLING FIRM:
Siemens Medical Systems, Inc. Hoffman Estates, IL.

RECALLED BY:
Manufacturer, by letter on 5/30/01.

FIRM INITIATED RECALL:
Ongoing.

DISTRIBUTION:
Nationwide and Argentina, Brazil, Canada, China, Germany, Spain, Great Britain, Japan, Sweden, Turkey, Austria, Switzerland, Korea, Taiwan and the Netherlands.

QUANTITY:
109 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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