Z-0144-2015Class II

IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical...

Name: Z-0144-2015 IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical...
Creator: IMRIS Inc
Published: 2014-10-01
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2014-10-01 / Terminated

FDA source

IMRIS Inc began a recall of IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient on 2014-10-01. FDA classified it as Class II and gives the reason as "One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0144-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Posted: 2014-10-28
Terminated: 2015-02-20
Recalling firm: IMRIS Imaging, Inc.
Product: IMRIS Operating Room table (ORT200 and ORT300). 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: One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.
FDA root cause: Use error
Action: Consignees were sent on 10/01/2014 an IMRIS "Urgent Field Safety Notice" letter dated September 25, 2014. The letter described the problem and the product involved in the recall. The letter informed consignees that the pins will be replaced with pins made of non-ferrous material. Customers are to ensure that users are aware of the changes and the existing procedure for table alignment and managing ferrous content in the magnet room. Contact customer support at 1-866-475-0525 for questions.
Quantity in commerce: 14
Distribution: Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
Product codes and lots: 10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0144-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0144-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)