—#64977

Product

Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K002584, K003541, K940478, K962797
Affected lot / code info: Serial Numbers: 401010, 401014, P0006939-0401002, P0006939-0401007, P0006939-0401008, and P0006939-0401012

Why it was recalled

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)

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA Inc
Address: 810 Innovation Dr, Knoxville, Tennessee 37932-2562

Distribution

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.

Timeline

Recall initiated: 2007-07-23
Posted by FDA: 2008-01-04
Terminated: 2009-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64977. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.