Monaco (2021-08-10)

Starting date:

August 10, 2021

Posting date:

August 19, 2021

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-76257

Last updated: 2021-08-19

• Reason
• Affected products

Affected Products 

Monaco

Reason

Within offline Monaco, if a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams. When the plan is reloaded into planning, the user cannot re-assign the couch to the beams for calculation because the option is disabled. Therefore, the patient will be underdosed.

Affected products