Recall Z-2088-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
| Date | Jun 29, 2016 (initiated May 9, 2016) |
| Status | Terminated |
| Reason | Software error in previous software versions in which two references for the same image may exist in the database. |
| Root cause | Software design |
| Action | Siemens sent an Customer Information letter dated May 10, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter with software instruction to customers informing them about an upcoming software VB10B under(SY003/16/P) update change and issue that the new software version will address. For further questions, please call (610) 448-6478. |
| Quantity | 74 systems |
| Distribution | US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093612 | SYNGO.PLAZA Siemens AG Medical Solutions, Mar 4, 2010 |