Recall Z-2719-2015 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comp
| Date | Sep 2, 2015 (initiated Jul 6, 2015) |
| Status | Terminated |
| Reason | Potential issue leading to data loss and patient data mix-up |
| Root cause | Software design |
| Action | Siemens sent a Customer Information letter, dated July 6, 2015, to customers The letter identified the affected product, problem and action to be taken. The letter informed cusotmers about the Hotfix software update that was being released. |
| Quantity | 37 |
| Distribution | US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093612 | SYNGO.PLAZA Siemens AG Medical Solutions, Mar 4, 2010 |