Inc ClassII Siemens Medical Systems

Compnay: Siemens Medical Systems, Inc
Date of Enforcement Report: 9/12/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0851-1
ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203. Codes: All E.CAM gamma cameras with the Profile option with ICON-P workstations and ICON software revision 8.1 or greater

REASON:
Artifacts on images from profile scans

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

RECALLED BY:
Manufacturer, There was no end user notification other than the statement “Please install ICON 8.5 (Rev. 02) software on all ICON P workstations which processProfile studies.”, which was included in the “What’s New for ICON 8.5” letter
sent to ICON Users that was revised in February 2000.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
National and International

QUANTITY:
125 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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