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Recall Observatory FDA recall evidence

Device product

IMRIS T2X Table, Part Number 109682-600

Z-0976-2018

February 20, 2018

Class II

Product summary

Firm
Deerfield Imaging, Inc.
Event
Event 79360
Status
Terminated
Classification
Class II
Quantity
16 tables
Official record key
device-enforcement:Z-0976-2018

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: 10000239, 10001306, 10000983, 10000982, 10000233, 10001119, 10001192, 10002375, 10003623, 10003623, 05 002, 10003634, 10001118, 10001188, 10001340, 10003638

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.