IMRIS Inc: Medical Device Recall in 2014 - (Recall #: Z-0144-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Product Classification:

Class II

Date Initiated: October 1, 2014
Date Posted: November 5, 2014
Recall Number: Z-0144-2015
Event ID: 69265
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.

Status: Terminated
Product Quantity: 14
Code Information:

10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.

Distribution Pattern:

Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.

Voluntary or Mandated:

Voluntary: Firm initiated