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Mingwei

MingWei Medical Technology(Suzhou)Co.,LTD · Model MWHX7110B · UDI-DI 26973915530147

510(k) clearances

Adverse events

Recalls

Facilities

Description

A metallic case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles.

Recalls

Date	Firm	Reason
2005-04-07	Dunlee	The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
2005-04-07	Dunlee	The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
2005-04-07	Dunlee	The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
2004-04-12	Fischer Imaging Corporation	X-ray tube may overheat after high usage because of mis-wired thermal switch circuit.

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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.