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SCANCOAT

DOMICO MED-DEVICE, LLC · Model 14-SCB · UDI-DI 00810050243339

KXJ IWY CCX

510(k) clearances

418

Adverse events (7 deaths)

Recalls

Facilities

Description

SCANCOAT®, KIT, ORTHOPEDIC. Includes: 102-SCB - SCANCOAT®, HOLDER, ADULT AP-PA HEAD (00810050241892), 121-SCB - SCANCOAT®, BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241816), 133-SCB - SCANCOAT®, REST, CERVICAL HEAD (00810050241960), 145-SCB - SCANCOAT®, WEDGE, 7” x 7” x 21.25” (00810050242042), 169-SCB - SCANCOAT®, RECTANGLE, 3” x 7.5” x 10” (00810050241939)

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.