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Blue Diamond
David Scott Company · Model BD080-FWa · UDI-DI 15060797551118
8
510(k) clearances
892
Adverse events (2 deaths)
8
Recalls
287
Facilities
Description
Adjustable Foot Board to be attached to the end of a surgical table. The footboard can be installed vertically or horizontally to suit the need. It has flat bars that adjust in & out for various table widths. From 20" to 22". The footboard can support up to 350 lbs. and includes a foam pad. The surface areas is 20" x 12.5".
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-12 | Sarnova HC, Llc | Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2014-05-08 | Covidien LLC | Straps may separate from the foam pad. |
| 2011-11-16 | Allen Medical Systems, Inc. | C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity |
| 2007-11-27 | Allen Medical Systems, Inc. | Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.