| Class 2 Device Recall Civco Belly Board, REF 126000 | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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