Recall Z-1218-2018— Deerfield Imaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Deerfield Imaging, Inc., initiated 2018-02-23, terminated 2019-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.. Reason: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked..
- Recalling firm
- Deerfield Imaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-23
- Terminated
- 2019-08-27
- Firm location
- Minnetonka, MN, United States
Product description
IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Reason for recall
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Data sourced from openFDA. This site is unofficial and independent of the FDA.