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SEDECAL

SEDECAL · Model SM-IV · UDI-DI 08436046003286

IZL Prescription

510(k) clearances

922

Adverse events (8 deaths)

170

Recalls

Facilities

Description

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

Recalls

Date	Firm	Reason
2026-06-05	GE Medical Systems, LLC	GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been
2026-06-05	GE Medical Systems, LLC	GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been
2026-06-05	GE Medical Systems, LLC	GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been
2026-03-27	Micro-X Ltd.	X-Ray generator may malfunction resulting in the X-Ray being inoperable.
2025-10-07	NeuroLogica Corporation	The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
2025-06-10	SEDECAL SA	Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clea
2025-06-10	SEDECAL SA	Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clea
2025-06-10	SEDECAL SA	Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clea
2025-06-10	SEDECAL SA	Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clea
2025-06-10	SEDECAL SA	Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clea

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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.