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Recall Observatory FDA recall evidence

Derived label

Device software or design

Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
defect where the error couch motion signal of couch firmware
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Philips Healthcare (Suzhou) Co., Ltd.

Field note

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