Siemens Medical Solutions USA Inc Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
Brand
Siemens Medical Solutions USA Inc
Lot Codes / Batch Numbers
Serial Numbers: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1010, 1012, 1013, 1014, 1015, 1016, 1017, 1018, and 1019
Products Sold
Serial Numbers: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1010, 1012, 1013, 1014, 1015, 1016, 1017, 1018, and 1019
Siemens Medical Solutions USA Inc is recalling Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens Medical So due to Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combinat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026