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Recall Observatory FDA recall evidence

Device product

IMRIS ORT100 Table, Part Number 110470-000

Z-0975-2018

February 20, 2018

Class II

Product summary

Firm
Deerfield Imaging, Inc.
Event
Event 79360
Status
Terminated
Classification
Class II
Quantity
15 tables
Official record key
device-enforcement:Z-0975-2018

Official wording

Reason: The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.

Code information: Serial Numbers: 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10002848, 10003241, 10005651, 10007348, 10007424, 10006886

Distribution pattern: US, Canada, Australia, China, Qatar

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.