FDA Device recall Z-0428-2013
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…
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of 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… by Innovative Magnetic Resonance Imaging Systems, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0428-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-19 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Innovative Magnetic Resonance Imaging Systems |
| Distribution | US |
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.
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.
Identifiers
| code_info | 10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847,…10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0428-2013%22
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