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DOMICO MED-DEVICE, LLC · Model 8-UF · UDI-DI 00810050245128

KXJ IWY CCX

510(k) clearances

418

Adverse events (7 deaths)

Recalls

Facilities

Description

KIT, SMALL "E". Includes: 101-UF - BLOCK, BASALAR, 7” x 16” x 12” (00810050244954), 102-UF - HOLDER, ADULT AP-PA HEAD (00810050244107), 104-UF - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050244466), 128-UF – WEDGE, 3” x 10” x 10” (00810050243148), 129-UF – WEDGE, 4.63" x 10" x 10" (00810050240864), 130-UF – WEDGE, 10" x 10" x 10" (00810050243155), 131-UF – RECTANGLE, 4” x 10” x 10” (00810050244442), 136-UF – WEDGE, 2.25” x 8” x 10” (00810050243117), 138-UF – WEDGE, 3.75” x 8” x 10” (00810050244152), 140-UF – WEDGE, 6" x 10" x 10" (00810050243162)

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

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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.