| Class 2 Device Recall IMRIS ORT100 and ORT 200 | |
Date Initiated by Firm | October 19, 2012 |
Date Posted | November 21, 2012 |
Recall Status1 |
Terminated 3 on December 11, 2012 |
Recall Number | Z-0428-2013 |
Recall Event ID |
63500 |
510(K)Number | K061916 K071099 K083137 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product | 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. |
Code Information |
10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513 |
Recalling Firm/ Manufacturer |
Innovative Magnetic Resonance Imaging Systems Inc. 78 Innovation Drive Winnipeg Canada Manitoba
|
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 23 |
Distribution | Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LNH
|
|
|
|