Recall Z-0802-2014 ยท IYE Accelerator, Linear, Medical
Civco Medical Instruments Inc
Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, 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.
| Date | Jan 21, 2014 (initiated Oct 25, 2013) |
| Status | Terminated |
| Reason | Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. |
| Root cause | Device Design |
| Action | Civco Medical Instruments Inc sent a FIELD SAFETY NOTIFICATION letter dated October 28, 2013 via UPS to their customers. The notification identified the affected device, problem, and field safety corrective action. The letter describes how customers can check to see whether the scales on their device are out of alignment. The letter states CIVCO will rework the system to correct the difference. For questions contact sales representative at CIVCO Medical Solutions, Radiation Oncology at 800-842-8688 or 712-737-8688. |
| Quantity | 138 belly boards |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121545 | BELLYBOARD, SBRT ACCESSORIES Medtec Inc. Dba Civco Medical Solutions, Jun 8, 2012 |