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Recall Observatory FDA recall evidence

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

September 21, 2020

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.no_named_rule · v1.0.0

    Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).