Health product recall

Lunar Prodigy (2018-03-20)

Starting date:
March 20, 2018
Posting date:
April 13, 2018
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-66418

Affected products

Lunar Prodigy

Reason

Under certain conditions, when using DICOM worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patient's name in the PACS.

Affected products

Lunar Prodigy

Lot or serial number

ENCORE SOFTWARE VERSIONS 9.0 to 10.0

Model or catalog number
  • PRODIGY
  • PRODIGY ADVANCE
Companies
Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

3030 Ohmeda Drive

Madison

53718

Wisconsin

UNITED STATES