Civco Belly Board MRI Recalled Due to Misaligned Scales
Civco Medical Instruments is recalling specific lots of Belly Board MRI devices because scales may be misaligned, potentially affecting measurement accuracy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves measurement inaccuracy rather than a direct physical hazard like injury or death, fitting the Moderate category for minor functional defects.
Plain-English summary
Civco Medical Instruments Inc is recalling the Civco Belly Board MRI, a reusable non-sterile glass fiber belly board with cushion (REF 126000). The recall involves two units from lot numbers M551490 and M550150. This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
The recall was initiated because scales adhered to the product may be misaligned from the zero reference, causing one side to not match the other. This defect could compromise the accuracy of the device's measurements.
The affected products were distributed worldwide, including nationwide in the United States and in various foreign countries such as Brazil, Canada, and Germany. Users should stop using the affected devices and contact Civco Medical Instruments for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Civco Medical Instruments Inc
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot#'s: M551490 and M550150
Distribution
Part of a larger recall action
This product is one of 2 recalled by Civco Medical Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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