Device product
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Z-0298-2021
Product summary
- Event
- Event 86512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-0298-2021
Official wording
Reason: Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
Code information: Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383
Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.
Derived failure modes
-
Unknown
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).