FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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.
- Recall number
- Z-1349-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-01-18
- Posted
- 2016-04-07
- Terminated
- 2017-08-03
- Reason
- To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
- Root cause
- Software design
- Action
- Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D.
- Quantity
- 49 imaging systems
- Distribution
- US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
- Lot, serial or model codes
- Model # 10014063
- 510(k) numbers
- ["K071114","K081734"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28