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