RADREX-i (2018-09-12)

Starting date:

September 12, 2018

Posting date:

September 28, 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-67858

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  Reason
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  Affected products

Affected products

RADREX-i

Reason

When the user performed radiography with wireless X-Ray Detector TFP-4336W, a message window was displayed on a monitor that said image transmission had not completed with no radiographic image. It also showed "ok" button to reacquire image data from the x-ray detector and "cancel" button to cancel the reacquisition. The user selected "ok" button, but the same message window appeared again. The user repeated the same operations several times and finally he/she selected "cancel" button to quit the re-acquisition mode. After system was restarted, the system worked normally.

Affected products