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.
FDA Recall Z-0405-2018 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2017-07-25
Date Terminated2018-07-23
Product Quantity36 units.
Reason for Recall
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
Firm 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 update has been fully completed. For further questions, please call (610) 448-6461.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.