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

FDA device recall Z-1518-2016 · posted 2016-04-19 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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.

Action taken

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

Status

Terminated

Product code

JAK

Quantity affected

1096

Distribution

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,

Date initiated

2016-03-02

Date posted

2016-04-19

Date terminated

2016-12-13

Location

Malvern, PA

Related 510(k) clearances