Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0802-2014·Announced 2014-01-29

Civco Belly Board Recalled Due to Misaligned Scales

Civco Medical Instruments is recalling 138 belly boards because scales may be misaligned from the zero reference, potentially affecting measurement accuracy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 a functional measurement error (misaligned scales) rather than a direct physical hazard like injury or contamination, fitting the criteria for moderate severity.

Plain-English summary

Civco Medical Instruments Inc is recalling 138 units of the Civco Belly Board, a reusable non-sterile carbon fiber belly board with cushion (REF 125012). The device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

The recall is due to a defect where scales adhered to the product may be misaligned from the zero reference, causing one side to not match the other. This misalignment could affect the accuracy of the device's intended function.

The affected products were distributed worldwide, including nationwide in the United States and in various foreign countries. Consumers and healthcare facilities should stop using the affected belly boards and contact Civco Medical Instruments for further instructions.

The recalled product

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.
Manufacturer: Civco Medical Instruments Inc
Category: Medical Device — Radiation Therapy Accessories
Hazard: mis-labeling
Affected units: 138

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 (20)

Lot #'s: M441670
M469970
M469980
M469990
M484910
M484920
M516200
M516210
M516220
M533340
M533350
M533360
M533370
M533380
M533970
M533980
M533990
M534000
M544650
M544660

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Civco Medical Instruments Inc

See all →

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Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks
FDA (Devices) · 2015-04-15
Moderate
Civco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak
FDA (Devices) · 2014-09-03
Moderate
Civco Belly Board MRI Recalled Due to Misaligned Scales
FDA (Devices) · 2014-01-29
High
CIVCO General Purpose Sensor Recalled for Calibration Errors
FDA (Devices) · 2012-07-18
High
Civco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors
FDA (Devices) · 2012-07-18

Same hazard · mis labeling