Reported May 8, 2013 · Terminated

Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding…

GE Healthcare, LLC

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: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Lot codes and dates
  • 85 of 85 codes

    • 08022011-001
    • 09092011-001
    • 12102011-001
    • 05152012-004
    • SM11062012-001
    • 02022012-001
    • 08142012-001
    • 04212012-001
    • 05252012-002
    • 12132011-001
    • SM08292012-007
    • 11052011-002
    • 01192012-001
    • 01132012-001
    • 06282012-010
    • 07252012-001
    • 01022012-001
    • 11202011-001
    • 08142011-001
    • 06302011-001
    • 09172011-001
    • 10082011-001
    • 10172011-002
    • 03142012-007
    • 06142012-001
    • 06212012-001
    • 07172012-001
    • 07232012-001
    • SM09132012-003
    • 02042012-001
    • 01132012-001
    • 07172011-001
    • 09062011-001
    • 09242011-001
    • SM10122012-003
    • M12102012-003
    • 05102012-004
    • 08022012-003
    • 07302012-008
    • SM01072013-005
    • 05032012-004
    • 08032012-001
    • 10172011-001
    • SM08152012-001
    • 12262011-001
    • 10092011-001
    • 04172012-001
    • 11052011-001
    • 07112011-001
    • 10242011-007
    • 07222011-001
    • 08102011-001
    • 03092012-001
    • 05172011-001
    • 06222011-001
    • 03202012-004
    • 05182012-001
    • 07112012-002
    • 06092011-001
    • 01232012-001
Amount recalled
81

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 25, 2013 · Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.