Recalls / —

—#84556

Product

Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Intended use: medical charged-particle radiation therapy system

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K072485

Affected lot / code info

Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Basic part number 8151289. Optional parts: Syngo RT Therapist assist part number 8162807, Therapist Express Assist part number 8151297.

Why it was recalled

Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.

Root cause (FDA determination)

Software design

Action the firm took

The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation. If you have any questions, call 1-925-602-8157.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern

Worldwide distribution: USA and countries including: Germany, France, Poland, Norway, Australia, Malaysia, Spain, New Zealand, the UK, India, Republic of Korea, Canada, Ireland, Italy, Egypt, Belgium, Philippines, Saudi Arabia, Netherlands, Hungary, Norway and South Africa.

Timeline

Recall initiated

2009-07-30

Posted by FDA

2011-02-08

Terminated

2011-04-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #84556. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.