FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo Imaging VB36D_HF02. Radiological image processing system.
- Recall number
- Z-0319-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo Imaging VB36D_HF02. Radiological image processing system.
- Status
- Terminated
- Initiated
- 2015-10-28
- Posted
- 2015-11-20
- Terminated
- 2016-10-06
- Reason
- To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.
- Root cause
- Software change control
- Action
- Siemens sent an Customer Information Letter dated October 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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 device's 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) 219-6300.
- Quantity
- 3
- Distribution
- US Distribution to the states of : NC, NE and OH.
- Lot, serial or model codes
- model# 10014063 and 10014064
- 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