Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innov

FDA device recall Z-0250-2008 · posted 2008-01-04 · Terminated

Recall details

Recalling firm: Siemens Medical Solutions USA Inc
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)
Action taken: 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
Status: Terminated
Product code: KPS
Quantity affected: 6 units
Distribution: 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, Ir
Date initiated: 2007-07-23
Date posted: 2008-01-04
Date terminated: 2009-09-11
Location: Knoxville, TN

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