Kodak Directview DR 7500 System and DRX-Evolution Systems (2013-12-02)

Starting date:

December 2, 2013

Posting date:

February 3, 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-37531

• Reason
• Affected products

Recalled Products

1. Kodak Directview DR 7500 System
2. DRX-Evolution System / Premium OTC-FF Wallstand - No Table -1DRXGOS
3. DRX-Evolution System / Premium OTC-FF Wallstand - Premium Table - 1DRXGOS
4. DRX-Evolution No System with Non-Motorized OTC
5. DRX-Evolution / Motorized OTC-FF Wallstand
6. DRX-Evolution System with Motorization-Fixed Wall Detector / Mobile CSI Table Detector

Reason

Carestream has identified that the wall stand (WS) bucky may continue moving downward when releasing the motorized WS keypad button. The number of reported occurrences represents less than 1% of the DRX-Evolution systems installed since 2009. There have not been any reported occurrences for the DR 7500 system.

Affected products