Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product U
FDA device recall Z-0802-2014 · posted 2014-01-21 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Inc
- Reason for recall
- Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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 ma
- Date initiated
- 2013-10-25
- Date posted
- 2014-01-21
- Date terminated
- 2017-02-02
- Location
- Kalona, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BELLYBOARD, SBRT ACCESSORIES (K121545) | Medtec Inc. Dba Civco Medical Solutions | 2012-06-08 |