Recall Z-0405-2018— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0405-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-25

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2017-07-25, terminated 2018-07-23. It names one FDA 510(k) clearance: K081734. 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: Siemens is releasing a letter to inform about potential data loss relevant to diagnosis..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-25
Terminated: 2018-07-23
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K081734 — SYNGO IMAGING (VERSION V31)Siemens AG Medical Solutions·cleared 2008-07-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.