Recall Z-0976-2018— Deerfield Imaging, Inc.

Class II · Terminated

Class II FDA medical device recall by Deerfield Imaging, Inc., initiated 2018-02-20, terminated 2019-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: IMRIS T2X Table, Part Number 109682-600. 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..

Recalling firm
Deerfield Imaging, Inc.
Classification
Class II
Status
Terminated
Initiated
2018-02-20
Terminated
2019-08-27
Firm location
Minnetonka, MN, United States

Product description

IMRIS T2X Table, Part Number 109682-600

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.