Recall Z-0270-2008 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc
Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
| Date | Nov 29, 2007 (initiated Jul 23, 2007) |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | 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. |
| Quantity | 43 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |