Home › DOMICO MED-DEVICE, LLC › NA

NA

DOMICO MED-DEVICE, LLC · Model 3-8 · UDI-DI 00810050245333

KXJ CCX

510(k) clearances

418

Adverse events (7 deaths)

Recalls

Facilities

Description

KIT, SMALL. Includes: 110-8 - WEDGE, 3” x 3” x 7.25” (10810050245316), 111-8 - WEDGE, 6.75” x 6.75” x 7.25” (00810050245326), 112-8 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050244527), 113-8 - WEDGE, 2.25” x 9.5” x 7.25” (10810050244401), 114-8 - RECTANGLE, 2” x 7.5” x 9.5” (00810050240857)

Recalls

Date	Firm	Reason
2026-08-06	IMRIS Imaging Inc	The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This
2025-02-25	Baxter Healthcare Corporation	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25	Baxter Healthcare Corporation	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25	Baxter Healthcare Corporation	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25	Baxter Healthcare Corporation	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25	Baxter Healthcare Corporation	There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2021-08-25	Deerfield Imaging, Inc.	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2021-08-25	Deerfield Imaging, Inc.	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2021-08-25	Deerfield Imaging, Inc.	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2019-11-04	Villa Sistemi Medicali S.P.A.	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.