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Health product recall

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