—#144545

Product

Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K122471
Affected lot / code info: Model Number: 7740769 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.

Why it was recalled

Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.

Root cause (FDA determination)

Software design

Action the firm took

Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge, which could possibly cause scan aborts, res cans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium. Siemens mailed certified as well as via email distribution a Customer Advisory Notice to their customers to inform them about corrective actions for bug-fixing the following systems running with software version VA44A_SP3a, VA44A_SP3b, VA44A_SP3c, correction of potential safety issues. The issues described will be corrected with software VA44_SP4, handled as update CT051/15/P. Following the installation of this update, the mentioned malfunctions will be corrected.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Timeline

Recall initiated: 2016-03-02
Posted by FDA: 2016-04-19
Terminated: 2016-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144545. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.