—#75531

Product

CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052775
Affected lot / code info: Software versions: syngo MMW 2007C, syngo MMWP 2008A, syngo MMWP 2008B, syngo MMWP 2008C, syngo CT 2007A, and syngo CT 2008G.

Why it was recalled

Indicated orientation does not match actual orientation of the patient.

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider "no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via "Save Sets CT"-button." The firm also highly recommends for customers "to check the correct display of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect to the posterior marking in the image." The error should be fixed within certain upgrade and installation activities on the affected software.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-11-13
Posted by FDA: 2009-01-08
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.