Reported Jun 24, 2026 · Ongoing
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Medtronic Navigation, Inc.-Boxborough
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc.-Boxborough · 200 Beaver Brook Road · Boxborough, MA · 01719
Is this the product you have?
- Medtronic O-arm O2 Imaging System
- Model NumberBI70002000
- Lot codes and dates
- Model NumberBI70002000
- GTIN (Serial Numbers)
589 of 589 codes
00643169639683 (C1640)00643169651814 (C3815C3816C3817C3818C3891C3898C3899C3900C3901C3902C3903C3905C3990C3997C3998C3999C4001C4002C4003C4004C4059C4060C4061C4062C4063C4064C4065C4066C4067C4068C4116C4117C4118C4119C4120C4121C4122C4123C4130C4201C4202C4203C4356C4357C4360C4361)00763000132378 (C2096C2187)00763000355555 (C2768)00763000481599 (C3895C3996)00763000496586 (C3794C3896C4023C4031C4032C4043C4088C4092)
- Amount recalled
- 589 units
Where it was sold
Why it was recalled
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
This product could cause temporary or reversible health problems — stop using it.
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