Siemens Medical Solutions USA, Inc: 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

Recall number

Z-2243-2011

Recalling firm

Siemens Medical Solutions USA, Inc

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

Status

Terminated

Initiated

2011-03-31

Posted

2011-05-23

Terminated

2012-03-30

Reason

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

Software design

Action

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

Quantity

164 active devices

Distribution

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.

Lot, serial or model codes

Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; syngo RT Therapist Connect / MOSAIQ OIS Part number 08168754.

510(k) numbers

["K060226","K072486","K993425"]

PMA numbers

not on file

Product code

IYE

Firm FEI

2937457

Firm city

Concord

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy