Deerfield Imaging, Inc. Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Brand
Deerfield Imaging, Inc.
Lot Codes / Batch 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)
Products Sold
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)
Deerfield Imaging, Inc. is recalling Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic pr due to ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026