Recall Z-0405-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc.
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.
| Date | Jul 25, 2017 |
| Status | Terminated |
| Reason | Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. |
| Root cause | Software design |
| Action | Siemens sent an Urgent Customer Advisory Notice Letter to all customers. All versions before version VB36E_HF01 can be configured to behave like the version VB36E_HF01. Please contact your local CSE to configure this setting and to evaluate an eventual minor performance impact to the system.If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the devices new owner where possible. Please observe this safety notice and comply with the corresponding measure until the up |
| Quantity | 36 units. |
| Distribution | USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081734 | SYNGO IMAGING (VERSION V31) Siemens AG Medical Solutions, Jul 3, 2008 |