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Terminated

Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

FDA Recall Z-1521-2016 · Posted 2016-04-19

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-03-02
Date Terminated2016-12-13
Product Quantity1096

Reason for Recall

Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans 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.

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120579SOMATOM DEFINITION EDGESiemens Medical Systems, Inc. · 2012-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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