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Terminated

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.

FDA Recall Z-0428-2013 · Posted 2012-11-21

Recalling FirmInnovative Magnetic Resonance Imaging Systems Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2012-10-19
Date Terminated2012-12-11
Product Quantity23

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.

Firm Action

Consignees were sent on 10/19/12 a IMRIS "Urgent Medical Device Correction" letter dated October 16. 2012. The letter described the product and the problem involved in the recall. It also provided changes to the Operator's Manual and labeling which addresses the issue. Customers may contact 1-866-475-0525.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083137NEURO III-SVImris, Inc. · 2008-12-16K071099NEURO II-SE, MODELS: OR-DR-OR, OR-MBImris, Inc. · 2007-05-22K061916NEURO II-SE, MODELS OR-MB-DR AND OR-DRImris, Inc. · 2006-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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