Apr

2003

Inc Class II Cti Pet Systems

Company: Cti Pet Systems, Inc
Date of Enforcement Report: 4/9/03
Class: II

PRODUCT
ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems:

Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+,ECAT ART, ECAT EMERGE and ECAT ACCEL
CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL
Marconi Models: Magellan
Hitachi Models: Sceptre and Sceptre XL.
Recall # Z-0674-03.

REASON
Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.

CODE
All serial numbers of above indicated scanner models using ECAT System Software Versions V7.1.1b, V7.2, V7.2.1 and V7.2.2.

RECALLING FIRM/MANUFACTURER
Cti Pet Systems, Inc., Knoxville, TN, by letter beginning on March 4, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
444.

DISTRIBUTION
Nationwide and Internationally.

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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Inc Class II Cti Pet Systems

Amy Sellers

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