FDA
Food and Drug Administration · Recall Z-2451-2026 · May 19, 2026Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Medtronic Navigation, Inc.-Boxborough
The hazard
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 00643169651814 (C3815Model C3816Model C3817Model C3818Model C3891Model C3898Model C3899Model C3900Model C3901Model C3902Model C3903Model C3905Model C3990Model C3997Model C3998Model C3999Model C4001Model C4002Model C4003Model C4004Model C4059Model C4060Model C4061Model C4062Model C4063UPC 00643169639683UPC 00643169651814UPC 00763000132378UPC 00763000355555UPC 00763000481599UPC 00763000496586UPC 00763000496593UPC 00763000496609UPC 00763000496630UPC 00763000496647UPC 00763000496661UPC 00763000496678UPC 00763000496692UPC 00763000496708UPC 00763000496715UPC 00763000496722UPC 00763000616304UPC 00763000616397UPC 00763000616441UPC 00763000616458UPC 00763000616564UPC 00763000709365UPC 00763000709372UPC 00763000709389UPC 00763000709396Would you have heard about this one?
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