Z-2243-2011

ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist...

Name: Z-2243-2011 ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist...
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-03-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-03-31 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2011-03-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2243-2011
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-05-23
Terminated: 2012-03-30
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
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; syngo RT Therapist Connect / MOSAIQ OIS Part number 08168754.

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)