Recall Z-1267-2015 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
| Date | Mar 12, 2015 (initiated Feb 6, 2015) |
| Status | Terminated |
| Reason | Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues. |
| Root cause | Software design |
| Action | Siemens sent a Customer Advisory Notice dated February 6, 2015, to all customers via USPS Certified Mail. The notice identified the affected product, problem and actions to be taken. |
| Quantity | 12 |
| Distribution | US Nationwide Distribution in the states of PA, MA, MN, NY, SC, MD, NY, IL, OH, TX and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133589 | SOMATOM FORCE Siemens Medical Solutions USA, Inc., Apr 17, 2014 |