PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 31, 2018 Initiated: July 25, 2017 #Z-0405-2018

Product Description

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.

Reason for Recall

Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

Details

Units Affected
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.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 36 units..
Why was this product recalled?
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 31, 2018. Severity: Moderate. Recall number: Z-0405-2018.