FDA Device recall Z-0647-2019
IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage… by Deerfield Imaging, citing table may drift in the roll position while in use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0647-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-06 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Deerfield Imaging |
| Distribution | US |
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
Identifiers
| code_info | (a) 113821-000, Serial Numbers: 10002220 (b) 113821-600, Serial Numbers: 10002692, 10006152, 10007192, 10006991, 100…(a) 113821-000, Serial Numbers: 10002220 (b) 113821-600, Serial Numbers: 10002692, 10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005190, 10005189, 10006891, 10004997 (d) 114148-600, Serial Numbers: 10006891 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0647-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.