Health product recall

Monaco (2021-08-10)

Starting date:
August 10, 2021
Posting date:
August 27, 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-76311

Last updated:
2021-08-27

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

Monaco

Lot or serial number
  • (01)00858164002190(10) 5.40.00
  • (01)00858164002190(10) 5.40.01
  • (01)00858164002190(10) 5.40.02
  • (01)00858164002268(10) 5.51.10
Model or catalog number

MONACO

Companies
Manufacturer

ELEKTA, INC.

1450 Beale street, suite 205

63303