Kodak Directview DR 9000 System (2014-06-02)

Starting date:

June 2, 2014

Posting date:

June 18, 2014

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-40053

• Reason
• Affected products

Recalled Products

Kodak Directview DR 9000 System

Reason

Carestream has identified that in the case of a control system failure, the DR 9000 u-arm may move downward unexpectedly when the radiology technologist is positioning the equipment using the "up" or "down" device control buttons. This downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the emergency stop button is activated or the equipment bump sensor contacts an object. There is a potential for injury if this issue occurs for patients positioned under the u-arm for decubitus exams.

Affected products