Device 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.
Z-0803-2014
Product summary
- Event
- Event 66591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 belly board
- Official record key
device-enforcement:Z-0803-2014
Official wording
Reason: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Code information: Lot#'s: M551490 and M550150
Distribution pattern: 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.
Derived failure modes
-
Unknown
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.