FDA Medical Device Recalls (openFDA)
Deerfield Imaging, Inc.: IMRIS ORT100 Table, Part Number 110470-000
- Recall number
- Z-0975-2018
- Recalling firm
- Deerfield Imaging, Inc.
- Product
- IMRIS ORT100 Table, Part Number 110470-000
- Status
- Terminated
- Initiated
- 2018-02-20
- Posted
- not on file
- Terminated
- 2019-08-27
- 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.
- Root cause
- Device Design
- Action
- The firm disseminated the notices on 02/23/2018 and followed with emails on 02/26/2018. The notices stated: "To minimize the risk of injury, IMRIS is taking the following corrective actions: " ORT100 Table: The rotational locking mechanism shall be replaced in all ORT100 tables that do not contain the most current design. " T2X Table: Tables will have their rotational lock inspected. If components are worn or performance is other than intended, the rotational lock assembly will be serviced or replaced entirely. IMRIS has identified that your facility has one or more of these OR Tables which require evaluation. Please confirm details on page 2 and return your response to IMRIS.IMRIS Customer Service will contact you to implement this corrective action. IMRIS recommends these preventive actions: " Per the ORT Operator Manuals the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, back section, headrest, pendant connection and swivel release pedal free engagement " During usage, verify the table is locked by manually pushing the table to make sure it does not move rotationally. " If the rotational lock is observed to be not functioning properly, please contact IMRIS Customer Service. The appropriate competent authorities have been notified of this corrective action. IMRIS is committed to patient and user safety, and apologizes for any inconvenience that this may cause. Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@i mris.com if you have any questions or concerns."
- Quantity
- 15 tables
- Distribution
- US, Canada, Australia, China, Qatar
- Lot, serial or model codes
- Serial Numbers: 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10002848, 10003241, 10005651, 10007348, 10007424, 10006886
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KXJ
- Firm FEI
- 3010326005
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28