Z-0405-2018Class II

Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended...

Name: Z-0405-2018 Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2017-07-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-07-25 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate... on 2017-07-25. FDA classified it as Class II and gives the reason as "Siemens is releasing a letter to inform about potential data loss relevant to diagnosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0405-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-25
Posted: 2018-01-23
Terminated: 2018-07-23
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Customer Advisory Notice Letter to all customers. All versions before version VB36E_HF01 can be configured to behave like the version VB36E_HF01. Please contact your local CSE to configure this setting and to evaluate an eventual minor performance impact to the system.If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the devices new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 448-6461.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0405-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0405-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-23

Product code LLZ

K081734Class IISyngo Imaging (Version V31)Siemens AG Medical Solutions / cleared 2008-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)