FDA recall Z-0405-2018

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2017-07-25

Report date

2018-01-31

Termination date

2018-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0405-2018