Innovative Magnetic Resonance Imaging Systems Inc.: Medical Device Recall in 2012 - (Recall #: Z-0428-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

Product Classification:

Class II

Date Initiated: October 19, 2012

Date Posted: November 28, 2012

Recall Number: Z-0428-2013

Event ID: 63500

Reason for Recall:

IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.

Status: Terminated

Product Quantity: 23

Code Information:

10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513

Distribution Pattern:

Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated