Z-2586-2021Class II

Operating room table -

Name: Z-2586-2021 Operating room table -
Creator: Deerfield Imaging, Inc.
Published: 2021-08-25
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2021-08-25 / Terminated / root cause: design

FDA source

Deerfield Imaging, Inc. began a recall of Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a... on 2021-08-25. FDA classified it as Class II and gives the reason as "ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2586-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-25
Posted: 2021-09-28
Terminated: 2024-04-30
Recalling firm: IMRIS Imaging, Inc.
Product: Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Product code: KXJ Table, Radiologic
Reason for recall: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Root cause tag: design
FDA root cause: Device Design
Action: 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."
Quantity in commerce: 3 units
Distribution: Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
Product codes and lots: UDI: 00857534006462; Model Number: 114093-600; Serial Number: 10007411, 10002996, 10004515.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2586-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2584-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-28
Z-2585-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-28
Z-2586-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-28

Product code KXJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)