Recall Z-0495-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.p
| Date | Aug 18, 2017 |
| Status | Terminated |
| Reason | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders. |
| Root cause | Software design |
| Action | Siemens released a software update VB20A_HF04 and a Customer Information Letter was sent with Update Instruction SY010/17/P. Service reports for the affected sites will be monitored to ensure the recall was effective. For further questions, please call (610) 219-6461. |
| Quantity | 47 |
| Distribution | USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132532 | SYNGO.PLAZA VB10A Siemens AG Healthcare, Dec 9, 2013 |