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Varex Imaging

Varex Imaging Nederland B.V. · Model 12860-10 · UDI-DI 08718755000924

IZO Prescription

510(k) clearances

160

Adverse events (8 deaths)

Recalls

Facilities

Description

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.

Recalls

Date	Firm	Reason
2016-11-20	Shimadzu Medical Systems	Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
2011-01-17	Philips Healthcare Inc.	Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.
2010-06-14	Mallinckrodt Inc	Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lea
2007-03-09	GE Healthcare	GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has

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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.