—#127508

Product

Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101119
Affected lot / code info: material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272

Why it was recalled

An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.

Timeline

Recall initiated: 2014-05-15
Posted by FDA: 2014-07-17
Terminated: 2014-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127508. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.