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Recall Observatory FDA recall evidence

Device product

Cios care fusion system

Z-1954-2019

June 20, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83255
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1954-2019

Official wording

Reason: DAP chamber may be missing an insulating foil

Code information: material # 10308192 Serial # 31375

Distribution pattern: IL, NE

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    DAP chamber may be missing an insulating foil