Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0405-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 25, 2017

Date Posted: January 31, 2018

Recall Number: Z-0405-2018

Event ID: 78911

Reason for Recall:

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

Status: Terminated

Product Quantity: 36 units.

Code Information:

material 10014063 Serial numbers: 1334, 1065, 1417, 1043 1353,1491,1496, 1316, 1279, 1116, 1090, 1081, 1310, 1226, 1396, 1107, 1343, 1198, 1432, 1058, 1082 1055, 1049, 1329, 1490, 1083, 1053, 1079, 1218, 1451, 1386, 1064, 1500, 1005, 1322, 1074. Updated version 31 contains 2 improvements on front end for usability, such as query enhancements and calibration improvements

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.

Voluntary or Mandated:

Voluntary: Firm initiated