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Recall Observatory FDA recall evidence

Device product

BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments

Z-0281-2019

September 17, 2018

Class II

Product summary

Firm
Leica Microsystems, Inc.
Event
Event 81036
Status
Terminated
Classification
Class II
Quantity
876 devices (in U.S. and Canada)
Official record key
device-enforcement:Z-0281-2019

Official wording

Reason: The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.

Code information: Zebra Printer Model TLP3842 - Affected PSU Part Number 808113-001 or P1028888-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week); Zebra Printer Model GX4301 - Affected PSU Part Number 808101-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week).

Distribution pattern: Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.