Recalls / —

—#101206

Product

ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany. Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K080906

Affected lot / code info

The ARTISTE RT Therapist v4.2 and Oncologist v4.2 is used on the following: syngo RT Oncologist Part # 10652131; Therapist Express Basic, Part # 08151289; syngo RT Therapist, Part # 08162815; syngo RT Therapist Connect / MOSAIQ OSI, part # 08168754.

Why it was recalled

A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides preventive measure instructions for customers to use until an update for the system is available.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Poland, Saudi Arabia, South Africa, Spain, Sweden, and United Kingdom.

Timeline

Recall initiated

2011-06-03

Posted by FDA

2011-08-10

Terminated

2012-03-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #101206. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.