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Terminated

PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT

FDA Recall Z-0547-05 · Posted 2005-02-16

Recalling FirmCTI PET Systems Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2004-05-27
Date Terminated2008-10-07

Reason for Recall

Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.

Firm Action

Written notification was sent via letter on May 27, 2004 to the end users to alert the consignees of the problem. The corrective software was mailed on December 17, 2004.

Root Cause

Other

Distribution Pattern

Nationwide, Germany, Spain, Italy, Korea and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042467LSO PET/CT HIREZ 64Cti Pet Systems, Inc. · 2004-10-01K033431LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZCti Pet Systems, Inc. · 2003-11-20K023518ECAT LSO PET/CT 16Cti Pet Systems, Inc. · 2002-11-08K013504MODIFICATION TO: ECAT LSO PET/CT SCANNERCti Pet Systems, Inc. · 2001-10-31K002715ECAT PET SCANNERCti Pet Systems, Inc. · 2000-10-31

Official Source

View FDA Recall →

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

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