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Recall Observatory FDA recall evidence

Device product

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

Z-3190-2018

July 29, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 80905
Status
Terminated
Classification
Class II
Quantity
429 total
Official record key
device-enforcement:Z-3190-2018

Official wording

Reason: 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).

Code information: 164013 164011

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).