Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innova

FDA device recall Z-0269-2008 · posted 2007-11-29 · Terminated

Recall details

Recalling firm: Siemens Medical Solutions USA Inc
Reason for recall: 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.
Action taken: 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.
Root cause: Software design
Status: Terminated
Product code: KPS
Quantity affected: 105 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, Ja
Date initiated: 2007-07-23
Date posted: 2007-11-29
Date terminated: 2009-09-11
Location: Knoxville, TN

Recalls and clearances share one API, with change alerts when new recalls post.