Recall Z-0803-2014— Civco Medical Instruments Inc

Name: FDA recall Z-0803-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-25

Class II · Terminated

Class II FDA medical device recall by Civco Medical Instruments Inc, initiated 2013-10-25, terminated 2017-02-02. It names one FDA 510(k) clearance: K121545. 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.. Reason: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other..

Recalling firm: Civco Medical Instruments Inc
Classification: Class II
Status: Terminated
Initiated: 2013-10-25
Terminated: 2017-02-02
Firm location: Kalona, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K121545 — BELLYBOARD, SBRT ACCESSORIESMedtec Inc. Dba Civco Medical Solutions·cleared 2012-06-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

Data sourced from openFDA. This site is unofficial and independent of the FDA.