Eclipse Treatment Planning System

Starting date:

August 17, 2012

Posting date:

September 17, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-15530

• Reason
• Affected products

Recalled Products:

Eclipse Treatment Planning System

Reason

Eclipse treatment planning system where an outdated assigned Hounsfield Unit [Hu] value can be used for dose calculation when the clock on the Eclipse Client workstation is not synchronized with the database / system server. When the Eclipse client workstation clock is running behind the clock on the database / system server, it is possible that a change to the assigned HU value for a structure does not invalidate the density image stored in the cache, and for the subsequent dose and Monitor Unit [MU] calculation to be based on the outdated HU assignment. The resultant MUs may be higher or lower than expected, dependent on the specific HU assignments. Treatment of the patient using these values can therefore lead to under or over dose.

Affected products