Z-0674-03

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

Name: Z-0674-03 ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission...
Creator: Cti Pet Systems Inc
Published: 2003-03-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-03-04 / Terminated

FDA source

Cti Pet Systems Inc began a recall of 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... on 2003-03-04. The reason FDA records is "Incorrect patient information is displayed in the reconstructed images of a whole body patient scan". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0674-03
Status: Terminated
Initiated: 2003-03-04
Posted: 2003-03-21
Terminated: 2006-02-07
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
FDA root cause: Other
Action: Written notification was sent via letter with corrective software beginning on March 4 to the end users.
Quantity in commerce: 444
Distribution: Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland Netherlands, Austria, France, Turkey, Spain, Sweden, Korea, Saudi Arabia, Russia, PROC (China), Czech Republic, Denmark, Mexico, Slovakia, and Chile
Product codes and lots: 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

Product code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)