FDA Device

Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.

Hazard

Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.

What You Should Do

Remedy

A letter marked "Urgent" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.

Products

Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for
Brand
Siemens Medical Solutions USA, Inc
UPC
All products with COHERENCE Therapist RTT4.1

Units Affected

16