Recall Z-0647-2019— Deerfield Imaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Deerfield Imaging, Inc., initiated 2018-11-06, terminated 2021-07-25. FDA's recall record names no specific 510(k) clearance for this event. Product: IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.. Reason: Table may drift in the roll position while in use.
- Recalling firm
- Deerfield Imaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-06
- Terminated
- 2021-07-25
- Firm location
- Minnetonka, MN, United States
Product description
IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.
Reason for recall
Table may drift in the roll position while in use
Data sourced from openFDA. This site is unofficial and independent of the FDA.