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Recall Observatory FDA recall evidence

Derived label

Device software or design

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Biodex Medical Systems, Inc.

Field note

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