Mevatron Linear Accelerators (2020-02-17)
- Starting date:
- February 17, 2020
- Posting date:
- March 13, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72539
Last updated: 2020-03-13
Affected Products
Mevatron Linear Accelerators
Reason
Siemens Healthineers has identified potential safety issues when the following safety interlocks occur, and the user clears the interlock without having the interlock immediately analyzed by a specialized staff member (e.g. medical physicist):
-
- Name: MONITOR 2
- Description: Monitor 2 total dose coincidence.
- Intent: This interlock is intended to prevent overdose when the primary dose monitory system fails to complete the treatment.
-
- Name: TREATMENT TIME
- Description: Preset treatment time coincidence with actual treatment time.
- Intent: This interlock is intended to prevent overdose if preset treatment time is exceeded.
-
- Name: MONITOR SYNC (SW)
- Description: Excessive accumulated dose deviation detected between the primary and the secondary dose monitoring systems.
- Intent: This interlock is intended to prevent patient mistreatment due to the inaccurate monitoring of delivered dose.
When one or more of the above described interlocks occur, it may be assumed that there is an error in the dose monitor system.
In the event the interlock is cleared without following the instructions described in the Urgent Customer Safety Advisory Notification, the event may lead to an incorrect recording of the dose values in the OIS and the application of an overdose during the respective segment following the resumption of treatment.
Affected products
Mevatron Linear Accelerators
Lot or serial number
2559
Model or catalog number
1940035
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY