The Recall Desk
HighFDA (Devices)·Z-1704-2015·Announced 2015-06-10

Siemens syngo Workflow SLR Recalled for Potential Order Loss

Siemens Medical Solutions USA is recalling 131 syngo Workflow SLR systems because a software defect may cause order loss during restarts, leading to diagnosis delays.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (diagnosis delay) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 131 units of the syngo Workflow SLR digital radiology information system (RIS). The system is used for patient administration, examination, reporting, and system administration.

The recall is due to a potential software defect where order transactions from interfaced Hospital Information Systems (HIS) may be lost during a restart of interface processes when using the Order Batching feature. This loss of data can lead to delays in patient diagnosis.

The affected units were distributed nationwide. Siemens Medical Solutions USA, Inc. is the recalling firm. No specific dates or additional distribution details are provided in the source text.

The recalled product

Product
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, tr
Affected units
131

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)

  • Model Number 10558586

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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