device · product 1 of 2
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.
- Recall number
- Z-0802-2014
- Initiated
- October 25, 2013
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Civco Medical Instruments Inc
- Quantity
- 138 belly boards
App-derived interpretation
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
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: M441670, M469970, M469980, M469990, M484910, M484920, M516200, M516210, M516220, M533340, M533350, M533360, M533370, M533380, M533970, M533980, M533990, M534000, M544650, M544660, M544670, M550150, M551490, M554940, M554950, M556540, M556550, M559560, M560740, M575850, M578310, M581730, M591090, M591100, M591110, M591120, M591130, and M599570
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.