—#75462

Product

Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072485
Affected lot / code info: Part # 8139789, with Syngo RT Therapist version 4.1 build 67

Why it was recalled

Under certain conditions, the flat panel may move unexpectedly and collide with the patient.

Root cause (FDA determination)

Labeling design

Action the firm took

The firm issued an Urgent Medical Device Customer Safety Letter, dated 10/23/2008. With the letter included a detailed description of the issue, the condition under which this issue may occur, and recommendation to avoid them. Customers are to read the information carefully and distribute to the responsible persons. The Customer Safety Letter should be included their syngo RT Therapist Express manual and remain there until the next release of software is installed. In the interest of safety, the preventive measures should be performed and all affected personnel should be informed immediately. The firm is tracking responses via return cards and completion protocol.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada.

Timeline

Recall initiated: 2008-10-23
Posted by FDA: 2009-01-14
Terminated: 2010-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.