Z-1264-2018Class II

IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d)...

Name: Z-1264-2018 IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d)...
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 ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600 on 2018-02-23. FDA classified it as Class II and gives the reason as "The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1264-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Posted: 2018-03-28
Terminated: 2019-09-12
Recalling firm: IMRIS Imaging, Inc.
Product: IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
FDA root cause: Other
Action: The firm initiated their field notification on 02/23/2018 by letter. The notice stated the following: "It has recently come to our attention that the ORTT2X/100/200/300 tables may drift while in use, which could potentially result in unintended movement of the table. This may pose a risk of injury to the patient. To minimize these risks, IMRIS is taking the following corrective actions: " ORT T2X/100/200 tables: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do not pass the drift test, a hydraulc fluid flush and filter change will be performed. " ORT300 tables: all customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed.A drift test will also be performed. 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 ORT Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies. Before each surgery, inspect the table for any visibly loose components or hydraulic fluid leaks and check that the headrest and tabletop safety latches are secured. .Please contact customer support via our service line at 1-866-475-0525 or Email: [email protected] if you have any questions or concerns."
Quantity in commerce: 17 units
Distribution: US, Canada, China, Australia, Sweden, Germany
Product codes and lots: (a) 113821-000, Serial Numbers: 10006997, 10002220 (b) 113821-600, Serial Numbers: 10002692,10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005189, 10005190, 10006891, 10004997, 10004327 (d) 114148-600, Serial Numbers: 10005201, 10006891

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1264-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1263-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1264-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1265-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1266-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

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)