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U.S. Department of Health and Human Services

Class 2 Device Recall Civco Belly Board, REF 126000

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  Class 2 Device Recall Civco Belly Board, REF 126000 see related information
Date Initiated by Firm October 25, 2013
Date Posted January 21, 2014
Recall Status1 Terminated 3 on February 02, 2017
Recall Number Z-0803-2014
Recall Event ID 66591
510(K)Number K121545  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information Lot#'s: M551490 and M550150
Recalling Firm/
Manufacturer		 Civco Medical Instruments Inc
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact James Leong
319-248-6502
Manufacturer Reason
for Recall		 Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
FDA Determined
Cause 2		 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 in Commerce 2 belly board
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, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
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