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XM12 T

I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA · Model 0.1/0.3 · UDI-DI 08059307491273

ITY Prescription
10
510(k) clearances
55
Adverse events
4
Recalls
54
Facilities

Description

Rotating anode X-ray tube for radiography systems

Recalls

DateFirmReason
2005-04-07DunleeThe x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
2005-04-07DunleeThe x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
2005-04-07DunleeThe x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
2004-04-12Fischer Imaging CorporationX-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.