Advantx, Prestilix, Prestige, and Precision Systems (2013-11-11)

Starting date:

November 11, 2013

Posting date:

January 24, 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-37623

• Reason
• Affected products

Recalled products

1. Advantx RFX/SFX DS Digital Photspot
2. Advantx Legacy/Legacy D R/F System
3. Prestilix 1600x
4. Prestige VH R/F Remote Controlled Table
5. Precision 500E System

Reason

It has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. There is a potential that your system has not been installed per specified installation requirements. GE Healthcare is not aware of any fall of the overhead monitor suspension. However, missing screws may increase the risk for fall of the monitor suspension. No injury has been reported due to this issue. Missing screws may increase the risk for the monitor to fall.

Affected products