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Terminated

Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

FDA Recall Z-0247-2008 · Posted 2008-01-04

Recalling FirmSiemens Medical Solutions USA Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2007-07-23
Date Terminated2009-09-11
Product Quantity11 units

Reason for Recall

Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols)

Firm Action

A certified letter-Urgent Device Correction- dated June 15, 2007 was sent to all affected consignees on July 23, 2007 informing them of the problem (PET iterative reconstruction algorithm) and requesting as a short term fix that they discontinue the practice of operating using protocols other than the default Biograph. Software upgrades as the long term fix were promised in the Urgent Device Correction Notice. Updated information received October 4, 2007: a software patch to fix PETsyngo 5.0 was released, software patch to fix PETsyngo 4.x was released, and target date for the software patch to fix PETsyngo 3.2 and 3.4 is the end of November 2007.

Root Cause

Software design

Distribution Pattern

Worldwide-USA and countries of Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Japan, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovak Republic, Thailand, Turkey, and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003541DENLASER, MODEL 800CAO Group, Inc. · 2001-01-25K002584ECAT ACCEL PET SCANNERCti Pet Systems, Inc. · 2000-11-16K962797ECAT EXACT & ECAT EXACT HR+Cti Pet Systems, Inc. · 1996-10-15K940478ECAT PRTCti Pet Systems, Inc. · 1994-03-22

Official Source

View FDA Recall →

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

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