# K993425: Primus

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 26, 1999 after 45 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 50 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882729 (1988). 1 ancestor in all.
17 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882729: Mevatron, M 2 Class, Siemens Medical Laboratories, Inc. (1988) Summary page 1.

## Most influential descendants
- K031764: Oncor Avant-Garde with Coherence Workspaces (2003), 16 descendants of its own
- K060226: Oncor Expression (2006), 13 descendants of its own
- K072485: Artiste MV SA (2007), 11 descendants of its own
- K082775: Prescision Option (2009), 9 descendants of its own
- K090683: Syngo RT Therapist Connect (2009), 7 descendants of its own

## Recalls of this device
- Feb 18, 2020 · Class II · Z-1680-2020: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- Mar 20, 2019 · Class II · Z-1204-2019: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINA
- Feb 14, 2018 · Class II · Z-1397-2018: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- Feb 14, 2018 · Class II · Z-1402-2018: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- Feb 14, 2017 · Class II · Z-1489-2017: Software update
- Jan 25, 2017 · Class II · Z-1215-2017: Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead susp
- Jan 25, 2017 · Class II · Z-1432-2017: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to 
- Jul 26, 2016 · Class II · Z-2877-2016: Software patch installation to address several safety issues.
- Aug 5, 2015 · Class II · Z-2812-2015: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
- May 5, 2015 · Class II · Z-0168-2016: potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option
- Dec 19, 2014 · Class II · Z-1059-2015: A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, inc
- Dec 2, 2014 · Class II · Z-0980-2015: Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose mu
- Jul 18, 2013 · Class II · Z-2095-2013: Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the
- May 29, 2013 · Class II · Z-1663-2013: The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may hav
- Apr 4, 2013 · Class II · Z-1182-2013: Software update to fix multiple safety related issues.
- Apr 4, 2012 · Not classified · Z-1494-2012: The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging pan
- Jan 22, 2012 · Not classified · Z-1092-2012: Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.
- Dec 1, 2011 · Not classified · Z-0782-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Jun 3, 2011 · Not classified · Z-3003-2011: A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next
- May 25, 2011 · Not classified · Z-2789-2011: Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system
- Mar 31, 2011 · Not classified · Z-2243-2011: 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.
- Mar 31, 2011 · Not classified · Z-2216-2011: 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 
- Mar 24, 2011 · Not classified · Z-2190-2011: When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.
- Nov 4, 2010 · Not classified · Z-2643-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- Nov 4, 2010 · Not classified · Z-2644-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- Nov 4, 2010 · Not classified · Z-2640-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- Nov 4, 2010 · Not classified · Z-2641-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- Aug 21, 2009 · Not classified · Z-1970-2011: When editing the note type of a previously entered note, then reverting to the original type, data may be lost.
- Jan 11, 2008 · Not classified · Z-1396-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Jan 11, 2008 · Not classified · Z-1397-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Jan 11, 2008 · Not classified · Z-1398-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Dec 10, 2007 · Not classified · Z-1759-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Aug 7, 2007 · Not classified · Z-0687-2008: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This prob
- Aug 7, 2007 · Not classified · Z-0686-2008: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This prob
- Jul 27, 2007 · Not classified · Z-0850-2008: Door Hinge failures; loose or falling off (Stationary Structure Doors)
- Mar 23, 2007 · Not classified · Z-0380-2008: Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
- Mar 22, 2007 · Not classified · Z-0166-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0169-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0167-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0168-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Jan 8, 2003 · Not classified · Z-0355-06: Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.
- Mar 5, 13 · Class II · Z-1040-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1041-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1043-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1036-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1039-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1044-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1042-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1038-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1037-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin

## Indications for use
The intended use of the PRIMUS™ is to deliver x-ray radiation for therapeutic treatment of cancer. The intended use of the PRIMUS™ is the same as the MEVATRON™ M and has not changed as a result of the modification.

Source page: https://510kreport.com/device/K993425
Methodology: https://510kreport.com/methodology