Device product
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Z-0972-2015
Product summary
- Event
- Event 70016
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50
- Official record key
device-enforcement:Z-0972-2015
Official wording
Reason: Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.
Code information: model numbers: 10848281; 10848354
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.