Reported Nov 28, 2012 · Terminated
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and…
Innovative Magnetic Resonance Imaging Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Innovative Magnetic Resonance Imaging Systems Inc. · 78 Innovation Drive · Winnipeg, Manitoba · N/A
Is this the product you have?
- 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.
- Lot codes and dates
1000284510002341100032441000279410003243100036291000380110002654100027961000279510002846100028471000383010003064100052011000375410004513
- Amount recalled
- 23
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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