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Recall Observatory FDA recall evidence

Device product

Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.

Z-0359-2016

November 05, 2015

Class II

Product summary

Firm
ConMed Corporation
Event
Event 72586
Status
Terminated
Classification
Class II
Quantity
9 devices
Official record key
device-enforcement:Z-0359-2016

Official wording

Reason: Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.

Code information: Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006

Distribution pattern: Distributed in the states of CA, and TX and in the country of Mexico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.