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eFilm Workstation/eFilm Lite
- Starting date:
- December 6, 2016
- Posting date:
- December 16, 2016
- 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-61480
Reason
This issue happens for RF projection images [the 12 DICOM SOP classes]. If user measures on RF image, "cal" (calibration) is not displayed and measurement is not correct. The "cal" label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on pixel spacing.
Affected products
eFilm Workstation/eFilm Lite
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
EFILM01
Companies
- Manufacturer
-
Merge Healthcare Incorporated,
900 Walnut Ridge Drive,
Hartland
53029
Wisconsin
UNITED STATES