—#85282

Product

Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072485
Affected lot / code info: Product: syngo RT Therapist model/part #8162815 Product: syngo RT Therapist Assist model/part #8162807 Product: syngo RT Therapist Express Basic model/part #8151289 Product: syngo RT Therapist Express Assist model/part #8151289

Why it was recalled

A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear Accelerator's Syngo RT Therapist v4.1 Workspace (containing the Siemens brand of Verify and Record application called PRIMEVIEW) and the LANTIS Oncology Information System product.

Root cause (FDA determination)

Software design

Action the firm took

The firm issued a TH015/09/S Safety Modification syngo RT Therapist 4.1 Customer Advisory letter, dated September 10. 2009. the letter stated the reason for modification, the affected systems, working time, deadline, reimbursement, and reporting. The firm is preparing a software upgrade for the affected products to correct the problem. The letter was sent via certified mail.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.

Timeline

Recall initiated: 2009-09-10
Posted by FDA: 2009-11-05
Terminated: 2010-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85282. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.