Recall Z-0428-2013 ยท LNH System, Nuclear Magnetic Resonance Imaging
Innovative Magnetic Resonance Imaging Systems Inc.
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.
| Date | Nov 21, 2012 (initiated Oct 19, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling design |
| 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. |
| Quantity | 23 |
| Distribution | Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA. |
| FDA record | Open on fda.gov |