—#64983

Product

Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, 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: 3600041-00-0001001, 3600050-000001, 3600050-00-0001001, 3600050-00-0001002, 3600050-00-0001004, 3600059-00-0001001, 3600059-00-0001002, 3600059-00-0001006

Why it was recalled

Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.

Root cause (FDA determination)

Software design

Action the firm took

Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.

Timeline

Recall initiated: 2007-07-23
Posted by FDA: 2007-11-29
Terminated: 2009-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64983. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.