IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Ne
FDA device recall Z-0428-2013 · posted 2012-11-21 · Terminated
Recall details
- Recalling firm
- Innovative Magnetic Resonance Imaging Systems Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 23
- Distribution
- Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
- Date initiated
- 2012-10-19
- Date posted
- 2012-11-21
- Date terminated
- 2012-12-11
- Location
- Winnipeg Canada, Manitoba
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEURO III-SV (K083137) | Imris, Inc. | 2008-12-16 |
| NEURO II-SE, MODELS: OR-DR-OR, OR-MB (K071099) | Imris, Inc. | 2007-05-22 |
| NEURO II-SE, MODELS OR-MB-DR AND OR-DR (K061916) | Imris, Inc. | 2006-08-11 |