Device product
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Z-1342-2019
Product summary
- Event
- Event 82730
- Status
- Terminated
- Classification
- Class II
- Quantity
- 459 (116 US)
- Official record key
device-enforcement:Z-1342-2019
Official wording
Reason: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Code information: Serial Number 105121 105122 105123 105124 105125 111129 111130 111127 111106 111128 123245 123246 123240 123239 123244
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.
Derived failure modes
-
Unknown
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.