—#99529

Product

ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software. Distributed by Siemens, Healthcare, Concord, CA 94520 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 Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; syngo RT Therapist Connect / MOSAIQ OIS Part number 08168754.

Why it was recalled

Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.

Root cause (FDA determination)

Software design

Action the firm took

Siemens initiated an Urgent Medical Device Correction letter on March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: use only relataive table setup with all planned table values '0' if applicable. In cases where the treatment plan contains at least one table parameter other than '0' to consider the following: Use only one PVG plus resulting offset per fraction. Once an offset has been applied do not use 'apply offset' at RTT for any further offset. Select the PVG and treatment beams in the same auto-sequence. In case this is not possible, the table position for each treatment beam, in the fraction, needs to be verified separately (especially for treatments with beams having different table posiitons. If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position. In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI. Scenario 2 - Manual change of table posiiton followed by a PVG calculated offset. Always deliver the PVG's at the planned table position. Avoid manual change of table posiiton prior to applicaiton of PVG. Select the PVG and treatment beams in the same auto-sequence. In case this is not possible, the table position for each treatment beam, in the fraction, need to be verified separately (especially for treatments with beams having different table positions). If an in-session resumption or individual download of beams has to be performed, make sure that the treatment table is in the correct position. In order to prevent any unintended table movement select manual table movement for all directions in the syngo RT Therapist service UI. Customers were informed that a software update would be provided as soon as possible. Customers were asked to include the Customer Sa

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution - USA including CA, DE, FL, KY, LA, MA, MI, MO, NC, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV and the countries of Australia, Belgium, Canada, Croatia, Egypt, France, Germany, Hungary, India, Ireland, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Turkey, and the United Kingdom.

Timeline

Recall initiated: 2011-03-31
Posted by FDA: 2011-05-23
Terminated: 2012-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99529. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.