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FDA Medical Device Recalls (openFDA)

Siemens Medical Solutions USA, Inc: Syngo.Via VB20A model 1049610

Recall number
Z-1778-2018
Recalling firm
Siemens Medical Solutions USA, Inc
Product
Syngo.Via VB20A model 1049610
Status
Terminated
Initiated
2018-03-27
Posted
2018-05-09
Terminated
2020-06-15
Reason
Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
Root cause
Software design
Action
On 03/27/18 Firm became aware that recall was necessary Firm initiated recall on 03/27/18 via customer information letter SY007/18/P advising that corrected values modified in the report are not save. Software patch VB20A_HF05 is being released to resolve the matter
Quantity
not on file
Distribution
Nationwide
Lot, serial or model codes
All
510(k) numbers
K123375
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

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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

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