Navios 8 and 10 Colour Lasers (2013-08-28)

Starting date:

August 28, 2013

Posting date:

September 19, 2013

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-35751

• 
  Reason
• 
  Affected products

Recalled Products

A. Navios 8 Colors / 2 Lasers

B. Navios 10 Colors / 3 Lasers

Reason

Beckman Coulter has determined that when the maintenance log for December is printed or saved, entries for the subsequent eleven (11) months are lost and cannot be retrieved unless the database was backed-up prior to performing the print or save actions. For example, if December 2012 is printed or saved, any maintenance log entries for January-November 2013 will be lost. This issue can result in potentially incomplete maintenance log entries. No other report generator functions or patient results are affected by this issue.

Affected products