VITROS 5600 Integrated System (2016-02-17)

Starting date:

February 17, 2016

Posting date:

March 4, 2016

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-57412

• Reason
• Affected products

Affected Products

• A. VITROS  5600 Integrated System
• B. VITROS  5600 Integrated System

Reason

Ortho Clinical Diagnostics has initiated this recall notification due to a possibility of misconfigured electrical wiring in the power system on the VITROS 5600 integrated system. This creates a situation where an individual module intended to be shut off will remain on if only the associated power cord is unplugged. Note there are two power cords per VITROS 5600 system. Normal use, maintenance and troubleshooting on VITROS 5600 systems will not expose an operator to electrical hazards as a result of this issue. The electrical wires are located in an area that is intended to be accessed only by Ortho-trained service representatives. There is no risk to Ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the VITROS 5600 system as a whole prior to working on a component.

Affected products