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Health product recall

Proteus XR/A General Purpose Radiographic System and Precision 500D System (2014-01-27)

Starting date:
January 27, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-38545

Recalled Products

A. Proteus XR/A General Purpose Radiographic System

B. Precision 500D System

Reason

Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams are improperly displayed. If the user continues to attempt to select one of the exams when this issue has occurred the system will update the screen, and in doing so potentially select a different exam/patient. If the user does not notice this change and continues to perform the exam, the images will be placed in an incorrect patient file.

Affected products

A. Proteus XR/A General Purpose Radiographic System

Lot or serial number

S3918JA

Model or catalog number

00000094745HL7

Companies
Manufacturer

GE Hualun Medical Systems Co. Ltd.

No.1 Yong Chang North Road,, Beijing Economic Technological, Development Zone,

Beijing

100176

CHINA



B. Precision 500D System

Lot or serial number

S0915KE

Model or catalog number

00000080557HL2

Companies
Manufacturer

GE Hualun Medical Systems Co. Ltd.

No.1 Yong Chang North Road,, Beijing Economic Technological, Development Zone,

Beijing

100176

CHINA