FDA Device recall Z-1218-2018
IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to…
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to… by Deerfield Imaging, citing the rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1218-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-23 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Deerfield Imaging |
| Distribution | n/a |
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.
Identifiers
| code_info | Serial numbers: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, 10002255 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Deerfield Imaging
- Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #1196…
FDA Device · Class II · 2022-04-20 · Deerfield Imaging - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiograp…
FDA Device · Class II · 2020-01-08 · Deerfield Imaging
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1218-2018%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.