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Portable X-ray Unit

AJEX Meditech Ltd · Model AJEX240H · UDI-DI 08809259370138

IZL Prescription
1
510(k) clearances
922
Adverse events (8 deaths)
170
Recalls
78
Facilities

Description

AJEX240H is a portable X-ray unit designed for ease usage. Applying high frequency inverter type X-ray generator. - X-ray tube voltage(kV) : 40 ~ 120 kV - X-ray tube current time product(mAs) : 0.4 ~ 120 mAs

Recalls

DateFirmReason
2026-06-05GE Medical Systems, LLCGE 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
2026-06-05GE Medical Systems, LLCGE 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
2026-06-05GE Medical Systems, LLCGE 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
2026-03-27Micro-X Ltd.X-Ray generator may malfunction resulting in the X-Ray being inoperable.
2025-10-07NeuroLogica CorporationThe four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
2025-06-10SEDECAL SASedecal 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
2025-06-10SEDECAL SASedecal 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
2025-06-10SEDECAL SASedecal 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
2025-06-10SEDECAL SASedecal 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
2025-06-10SEDECAL SASedecal 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.