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FDR AQRO

FUJIFILM CORPORATION · Model DR-XD 1000 · UDI-DI 04547410339161

IZL Prescription

510(k) clearances

922

Adverse events (8 deaths)

170

Recalls

Facilities

Description

The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The DR-XD 1000 is not intended for mammography applications.

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.