FDA-Device2018-09-26Class II
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
Siemens Medical Solutions USA, Inc
Hazard
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Sold states
US nationwide distribution.
Affected count
429 total
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3189-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief