Data Foundry

Medical device recalls 2015

syngo Workflow SLR — Class II medical device recall Z-1704-2015

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-06-10, distributed nationwide. A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost

Recall numberZ-1704-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2015-05-06
Classified2015-06-02
Reported by FDA2015-06-10
Terminated2016-08-17
DistributedNationwide (US)
Quantity131
Serial numbers195000, 195004, 195006, 195007, 195012, 195016, 195017, 195019, 195020, 195021, 195023, 195024, 195027, 303198, 303602, 304907, 305086, 305185, 305193, 305664, 310003, 312116, 312298, 312538, 313510 and 106 more
Model numbers10558586

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, 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1704-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.