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Adept Medical Overhead Arm Support

ADEPT MEDICAL LIMITED · Model AM2000 · UDI-DI 09421905187183

CCX

510(k) clearances

892

Adverse events (2 deaths)

Recalls

286

Facilities

Description

Interventional Radiologists have requirement to carry out CT scans of patients for diagnostic and interventional procedures on a patient. This could be on an Angiography Table (Cone Beam CT) or within a CT Scanner (Conventional CT). Minimising X-ray artefact for these procedures is appealing hence the requirement to elevate the patients arms cranially to clear their torso, the region of interest. Interventional Radiologists also have requirement to raise arms clear of the patients torso sides to allow access for biliary drainage procedures. This device aims to facilitate both imaging and patient access application.

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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Data 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.