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Recall Observatory FDA recall evidence

Device product

Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041

Z-1992-2016

March 31, 2016

Class II

Product summary

Firm
Med Tec Inc
Event
Event 73692
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-1992-2016

Official wording

Reason: When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.

Code information: Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)

Distribution pattern: Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.