Health product recall

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