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MOSAIQ (2015-12-09)
- Starting date:
- December 9, 2015
- Posting date:
- December 24, 2015
- 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-56452
Recalled Products
A. MOSAIQ
Reason
Incorrect drug dosage due to "age limit" data item issue. When there is no valid (unexpired) patient weight entered on the same date or prior to a serum creatinine value being populated, a stale creatinine clearance (CRCL) value is being used in area under curve (AUC) dose calculations.
Affected products
A. MOSAIQ
Lot or serial number
v2.0 and higher
Model or catalog number
MOSAIQ
Companies
- Manufacturer
-
Elekta Business Area Software Systems IMPAC Medical Systems, Inc.
100 Mathilda Place, 5th floor
Sunnyvale
94086
California
UNITED STATES