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Recall Observatory FDA recall evidence

Derived label

Device software or design

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Inpeco S.A.

Field note

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