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.
Reported: May 8, 2013 Initiated: March 28, 2013 #Z-1212-2013
Product Description
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.
Reason for Recall
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 81
- Distribution
- Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 81.
Why was this product recalled? ▼
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2013. Severity: Moderate. Recall number: Z-1212-2013.
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