Carestream DRX-1 System

Starting date:

November 12, 2012

Posting date:

December 24, 2012

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-25851

• Reason
• Affected products

Recalled Products

1. Carestream DRX-1 System
2. Carestream DRX-1 System
3. Carestream DRX-1 System

Reason

A single occurrence of a cross wired appliance connector within a Carestream DRX-1 system console was discovered during system testing prior to shipment. Carestream has determined that a field inspection is necessary to ensure there are no consoles in the field with the cross wiring configuration.

If a cross wired console is in use, under the combination of circumstances where a facility does not have an intact electrical ground, an operator or service person is touching the console and another grounded surface, there could be a risk of severe electrical shock. This type of event is very unlikely as all of these circumstances must be true in order for the hazard to manifest.

Affected products