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Recall Observatory FDA recall evidence

Derived label

Device software or design

Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
firmware and the Automation software without any error
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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