PlainRecalls
FDA Devices Moderate Class II Terminated

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, transfers, exchanges, and prints.

Reported: June 10, 2015 Initiated: May 6, 2015 #Z-1704-2015

Product Description

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, transfers, exchanges, and prints.

Reason for Recall

A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.

Details

Units Affected
131
Distribution
Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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, transfers, exchanges, and prints.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 131.
Why was this product recalled?
A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2015. Severity: Moderate. Recall number: Z-1704-2015.