Recall Z-0862-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
| Date | Feb 23, 2016 (initiated Dec 22, 2015) |
| Status | Terminated |
| Reason | Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen. |
| Root cause | Software design |
| Action | Siemens sent a Voluntary Correction and Removal Action letter dated December 30, 2015. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that a software update VB10A_HF01/06 is being released simulataneously to eliminate the issue. Customers with questions were instructed to call 1-888-826-9702. |
| Quantity | 68 |
| Distribution | Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI |
| FDA record | Open on fda.gov |