Z-0803-2014Class II

Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per...

Name: Z-0803-2014 Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per...
Creator: Civco Medical Instruments Inc
Published: 2013-10-25
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2013-10-25 / Terminated / root cause: design

FDA source

Civco Medical Instruments Inc began a recall of 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... on 2013-10-25. FDA classified it as Class II and gives the reason as "Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0803-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-25
Posted: 2014-01-21
Terminated: 2017-02-02
Recalling firm: CIVCO Medical Instruments Co., Inc.
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Root cause tag: design
FDA 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 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.
Product codes and lots: Lot#'s: M551490 and M550150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0802-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21
Z-0803-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21

Product code IYE

K121545Class IIBellyboard, Sbrt AccessoriesMedtec Inc. Dba Civco Medical Solutions / cleared 2012-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)