[Recalled] 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 unde
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Civco Medical Instruments Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0802-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 October 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Civco Medical Instruments Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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