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Recall Observatory FDA recall evidence

Derived label

Device software or design

Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Philips Medical Systems (Cleveland) Inc

Field note

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