Z-3034-2026Class II

ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600

Name: Z-3034-2026 ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Creator: IMRIS Imaging Inc
Published: 2026-08-06
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2026-08-06 / Open, Classified / root cause: manufacturing process

FDA source

IMRIS Imaging Inc began a recall of ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600 on 2026-08-06. FDA classified it as Class II and gives the reason as "The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3034-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-06
Posted: 2026-08-26
Recalling firm: IMRIS Imaging, Inc.
Product: ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Product code: KXJ Table, Radiologic
Reason for recall: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 8/6/26 was sent to customers. IMRIS recommends the following preventative actions until the corrective actions have been implemented on your table: " 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 floor latching mechanism is observed to not function properly, please contact IMRIS Customer Service immediately. Please confirm receipt of this notice with IMRIS using the Customer Acknowledgement Form below, and please forward this communication to any others inside or outside your organization who may work with the affected ORT200 and ORT300 tables. To minimize the potential risk of injury, IMRIS is taking the following corrective actions: " The existing ORT200 and ORT300 linear actuator and rotational lock mechanism components will be replaced with an updated design. Our customer service organization will contact you to make arrangements for IMRIS field service personnel to perform the correction at your facility. IMRIS has identified that your facility has one or more ORT200 or ORT300 Operating Tables which are subject to this recall notice. Please confirm details on the last page of this letter and return your response to IMRIS. IMRIS Customer Service will contact you to facilitate replacement of the linear actuator and rotational lock mechanism components at your facility. Please contact our customer support team through our service line at 1-866-475-0525 or e-mail: [email protected] if you have any questions or concerns. Please keep this information until the corrective measures have been finalized.
Quantity in commerce: 13 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Product codes and lots: 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3034-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3033-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3034-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)