BonD-MaX and BOND-III System (2018-09-13)

Starting date:

September 13, 2018

Posting date:

October 5, 2018

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-67884

• 
  Reason
• 
  Affected products

Affected products

A. BonD‑MaX System

B. BOND-III System

Reason

This Field Action Notice applies to the Zebra Power Supply Unit (PSU) for the Zebra printer models Zebra TLP3842 (affected PSU part number 808113-001 or P1028888-001) and Zebra GX430t (affected PSU part number 808101-001. These were supplied by Leica Biosystems as part of the bond slide labeler for use with bond-iii and bond-max instruments.

The affected models of Zebra printers, which serve as the external power source for these printers, have been identified as potentially containing an improperly mixed phosphorus compound that is used in the flame retardant resin in the DC power supply connectors. This deficiency in the phosphorus based connector resin, when combined with moisture and humidity over time, can potentially lead to overheating or a fire hazard.

Affected products