Z-1218-2018Class II

IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic...

Name: Z-1218-2018 IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic...
Creator: Deerfield Imaging, Inc.
Published: 2018-02-23
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2018-02-23 / Terminated

FDA source

Deerfield Imaging, Inc. began a recall of IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position... on 2018-02-23. FDA classified it as Class II and gives the reason as "The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1218-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Posted: 2018-03-27
Terminated: 2019-08-27
Recalling firm: IMRIS Imaging, Inc.
Product: IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
FDA root cause: Under Investigation by firm
Action: The firm disseminated their notices on 02/23/2018 by mail and followed with an email on 02/26/2018. The notice stated: "It has recently come to our attention that the ORT200/300 rotational lock fails to operate such that it cannot change states between locked and unlocked. This may pose a risk of injury to the patient. To minimize the risk of injury, IMRJS is taking the following corrective actions: " ORT200 and 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary. 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 OAT 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 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@imris. com if you have any questions or concerns."
Quantity in commerce: 13 units
Distribution: US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
Product codes and lots: Serial numbers: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, 10002255

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1218-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1217-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1218-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code FQO

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)