Recall Z-1921-2019 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system ca
| Date | Jun 4, 2019 |
| Status | Terminated |
| Reason | The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan. |
| Root cause | Software design |
| Action | On June 4, 2019, the firm notified customers of the recall via Urgent Medical Device Correction letters. Customers were informed that the firm has developed software update CT VA20A-SP2A to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also improve some areas during the start-up and shut-down processes, as well as providing other improvements related to the system, examination and reconstruction processes, and dual energy and intervention . The corrective action will be provided free of charge and will be distributed via Update Instr |
| Quantity | 69 |
| Distribution | US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO Siemens Medical Solutions USA, Inc., Apr 13, 2018 |