Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording

FDA Recall Z-2878-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-07-26
Date Terminated2018-05-10
Product Quantity103 accelerators

Reason for Recall

Software patch installation to address several safety issues.

Firm Action

Siemens sent a Field Safety Notice to all affected customers informing them of a new software patch that they plan to install to address software issues. Customers were advised to notify anyone at their organization who should be aware of the information contained in the Notice. Customers were also advised to include the Field Safety Notice in their System Owner Manual, chapter "Safety Advisory Letters" where it should remain. For questions regarding this recall call 610-219-4834.

Root Cause

Software design

Distribution Pattern

Nationwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090683SYNGO RT THERAPIST CONNECTSiemens Medical Solutions USA, Inc. · 2009-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑