Z-0405-2018 Class II Terminated
FDA device recall Z-0405-2018 was initiated by Siemens Medical Solutions USA, Inc. on July 25, 2017 and is designated Class II. Reason for recall: Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. The recall status is terminated (terminated July 23, 2018). Affected quantity: 36 units..
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2018
- Initiation Date
- July 25, 2017
- Termination Date
- July 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units.
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.
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.
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