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Civco Medical Instruments Inc recalls Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Pr
Recalled January 29, 2014 · FDA recall Z-0803-2014 · Civco Medical Instruments
Hazard
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. · FDA Class II
Units
2 belly board
Sold at
Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
Description
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Product
Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Manufacturer(s)
Civco Medical Instruments Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →