The Recall Desk

FDA (Devices) recall action 66591

Civco Medical Instruments Inc recalled 2 products on 2014-01-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-01-29
Critical
0
Units
140

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··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.

    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.
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2014-01-29

    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.

    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.
    Category
    Distribution
    28 states