The Recall Desk
ModerateFDA (Devices)·Z-1622-2014·Announced 2014-05-28

Siemens syngo Imaging XS Software Recall Due to Data Deletion Risk

Siemens Medical Solutions is recalling 64 syngo Imaging XS systems because a software change may have caused the deletion of archived medical images.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential data loss (deleted medical images) rather than direct physical injury or death, fitting the criteria for moderate severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 64 units of the syngo Imaging XS Picture Archiving and Communication System (PACS). This software is used to display, process, store, and archive digital medical images to support physician diagnosis and treatment planning.

The recall was initiated after a complaint reported that the archiving method at one customer site was changed from implicit to explicit. The cleanup procedure associated with this explicit archiving method may have deleted data from the archive itself.

The affected units were distributed nationwide. Siemens Medical Solutions USA, Inc. is the recalling firm. Users of this software should contact the manufacturer for instructions on how to verify the integrity of their archived data and to receive any necessary corrective actions.

The recalled product

Product
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging
Hazard
Affected units
64

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • material number: 10014063

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →