—#99531

Product

ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. Distributed by Siemens Healthcare, Concord, CA 94520 Intended use: Radiation therapy

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226, K072486, K993425
Affected lot / code info: Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754.

Why it was recalled

Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Siemens, sent an "Urgent: Medical Device Correction Customer Safety Advisory Notice" on March 31, 2011 via Siemens Customer Service Group or certified mail to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to not use the "Online 2D Image Review" on the Syngo RT Oncologist 4.2; to always calculate the offset directly on the RTT 4.2 before it is applied for the treatment with the patient on the treatment table; include this notice in their syngo RT Therapist 4.2 System Owner Manual chapter "Safety Advisory Letter" where it should remain until the measures defined in the notice are performed, and in the interest of safety, perform the preventative measures noted in this notice and inform all affected personnel immediately. Siemens is currently working on a solution for the incremental loading workflow in syngo RT Therapist 4.2 and will provide a software update as soon as possible. Siemens will notify the customers as soon as an update for their system will be available. UPDATE: The release of Safety Update UI TH010/11/S to distribute the software update for RTTv4.2.94O04 began on April 15, 2011. If you have any questions, contact Regulatory Affairs at 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 (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom.

Timeline

Recall initiated: 2011-03-31
Posted by FDA: 2011-05-19
Terminated: 2012-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.