Recalls / —

—#93276

Product

Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Concord CA Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver 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

K072485, K090683

Affected lot / code info

All codes.

Why it was recalled

A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.

Root cause (FDA determination)

Other

Action the firm took

Siemens sent Urgent Medical Device Correction, Safety Advisory Notices to all affected customers on June 29, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their System Owner Manual, Chapter, "Safety Advisory Letter. For questions customers were instructed to contact their Siemens Service Engineer or Application Specialist. For questions regarding this recall call 925-602-8157.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern

Worldwide Distribution - USA including NC,OH, and the countries of Belgium, Sweden, Germany, Lebanon, Japan, Australia, and Iran.

Timeline

Recall initiated

2010-06-29

Posted by FDA

2011-03-04

Terminated

2012-03-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #93276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.