Siemens Syngo Dynamics-a Picture Archiving and Communication System — Class II medical device recall Z-1183-2016

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-03-23, distributed nationwide. Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version o

Recall number	`Z-1183-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated	2016-01-25
Classified	2016-03-17
Reported by FDA	2016-03-23
Terminated	2018-06-29
Distributed	Nationwide (US)
Quantity	228 units
Serial numbers	`4184`, `5387`, `85016`, `85017`, `85020`, `85021`, `85023`, `85024`, `85035`, `85036`, `85040`, `85041`, `85042`, `85045`, `85047`, `85049`, `85050`, `85051`, `85053`, `85054`, `85057`, `85060`, `85062`, `85066`, `85067` and 202 more
Model numbers	`10091637`, `10091673`, `10091805`, `10091807`

Product

Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.

Reason for recall

Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1183-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.