Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0674-03 · Posted 2003-03-21

Recalling FirmCti Pet Systems Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2003-03-04
Date Terminated2006-02-07
Product Quantity444

Reason for Recall

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

Firm Action

Written notification was sent via letter with corrective software beginning on March 4 to the end users.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002584ECAT ACCEL PET SCANNERCti Pet Systems, Inc. · 2000-11-16K962797ECAT EXACT & ECAT EXACT HR+Cti Pet Systems, Inc. · 1996-10-15K940478ECAT PRTCti Pet Systems, Inc. · 1994-03-22K920624ECAT EXACT HR MODEL 961Cti Pet Systems, Inc. · 1992-04-27K913637ECAT SCANNER (MODEL 921)Cti Pet Systems, Inc. · 1991-11-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑