Recall Z-0428-2013— Innovative Magnetic Resonance Imaging Systems Inc.
Class II · Terminated
Class II FDA medical device recall by Innovative Magnetic Resonance Imaging Systems Inc., initiated 2012-10-19, terminated 2012-12-11. It names 3 FDA 510(k) clearances: K083137, K071099, K061916. 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..
- Recalling firm
- Innovative Magnetic Resonance Imaging Systems Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-19
- Terminated
- 2012-12-11
- Firm location
- Winnipeg, Manitoba, Canada
510(k) clearances named in this recall
3 on FDA's record- K083137 — NEURO III-SV
- K071099 — NEURO II-SE, MODELS: OR-DR-OR, OR-MB
- K061916 — NEURO II-SE, MODELS OR-MB-DR AND OR-DR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.