Z-1601-2016Class II

Syngo Dynamics; Kinetdx Picture Archiving and Communications System

Name: Z-1601-2016 Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-04-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-04-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Dynamics; Kinetdx Picture Archiving and Communications System on 2016-04-14. FDA classified it as Class II and gives the reason as "Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in...". 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-1601-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Posted: 2016-05-04
Terminated: 2017-03-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
Root cause tag: software
FDA root cause: Software design
Action: Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed.
Quantity in commerce: 84 units
Distribution: Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
Product codes and lots: Model Numbers: 10091637, 10091673, 10091805, 10091807 Serial Numbers: 85021, 85040, 85042, 85045, 85047, 85057, 85079, 85080, 85081, 85086, 85090, 85115, 85143, 85145, 85146, 85147, 85149, 85157, 85167, 85168, 85170, 85172, 85177, 85178, 85185, 85186, 85189, 85191, 85234, 85235, 85239, 85281, 85307, 85309, 85322, 85325, 85326, 85329, 85335, 85338, 85350, 85353, 85354, 85368, 85370, 85374, 85377, 85380, 85385, 85387, 85401, 85418, 85421, 85422, 85427, 85435, 85442, 85447, 85462, 85467, 85468, 85469, 85470, 85473, 85481, 85482, 85484, 85859, 85860, 85866, 85867, 85871, 85872, 85873, 85874, 85875, 85876, 85880, 85883, 85884, 85893, 85896, 85910, 85918

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1601-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1601-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04

Product code LLZ

K023772Class IIKinetdx Picture Archiving and Communications SystemAcuson Corp. / cleared 2002-11-22

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)