Operating room table - Product Usage: intended for use… recallZ-2584-2021 · Deerfield Imaging, Inc. · initiated Aug 25, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Deerfield Imaging, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
FDA root cause category: Device Design
What the company is doing
A Recall notification letter titled, "URGENT FIELD CORRECTION NOTICE" was sent to consignees on 08/25/2021 via Fed-Ex. E-mail communications were also sent to the customers on 8/26/2021. The letter instructs the consignee to fill out the second page of the notice and return it to the firm. The letter states that the IMRIS Customer Service will contact the consignee to schedule implementation of this corrective action with the facility. The letter mentions that, "IMRIS recommends these preventive actions: Per the OR Table Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, tabletops, headrest, pendant connection and rotation. During usage, verify the table position is locked by manually pushing the table to ensure it does not exhibit rotational movement. If the rotational lock is observed to not function properly, please contact IMRIS Customer Service immediately."
Recall details
- Recall number
- Z-2584-2021
- Status
- Terminated
- Initiated by the company
- Aug 25, 2021
- Recalling firm
- Deerfield Imaging, Inc.
- Quantity
- 13 units
- Product code
- KXJ
- Distribution
- Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
Product description
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Code information (models, lots, serial numbers)
UDI: 00857534006738 and 00857534006349 Model Number: 113821-000 (Serial Number: 10002220); Model Number: 113821-600 (Serial Numbers: 10002692, 10006152, 10006991, 10004513, 10006997, and 10003754); Model Number: 114148-000 (Serial Numbers: 10004463, 10006891, 10005189, 10005190, 10004327, and 10004997)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ORT200 TableIMRIS Imaging, Inc. · Table, Operating-Room, Ac-Powered2 recalls12 reports
- ORT200 113821-000IMRIS Imaging, Inc. · Table, Operating-Room, Ac-Powered1 recall5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88661).
- Z-2585-2021 · TerminatedOperating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
- Z-2586-2021 · TerminatedOperating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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