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Class IIOngoingZ-2451-2026

Medtronic Navigation, Inc.-Boxborough recalls Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Medtronic Navigation, Inc.-BoxboroughBoxborough, MA, United StatesReported Jun 24, 2026 · 24 days ago
Legal News Analyst ·

Reason for recall

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Medtronic O-arm O2 Imaging System. Model Number:BI70002000
    Model Number
    400 affected lots
    0064316963968300643169651814C3816C3817C3818C3891C3898C3899
    +392 moreC3900C3901C3902C3903C3905C3990C3997C3998C3999C4001C4002C4003C4004C4059C4060C4061C4062C4063C4064C4065C4066C4067C4068C4116C4117C4118C4119C4120C4121C4122C4123C4130C4201C4202C4203C4356C4357C436000763000132378007630003555550076300048159900763000496586C3896C4023C4031C4032C4043C408800763000496593C3889C3978C3988C3991C3994C4041C4109C4110C4111007630004966090076300049663000763000496647C412600763000496661C3987C40710076300049667800763000496692C3823C3897C3979C4027C4037C4044007630004967080076300049671500763000496722C3822C3828C3881C4034C4036C4038C40390076300061630400763000616397007630006164410076300061645800763000616564C3735C3777C3778C3779C3780C3781C3786C3787C3790C3791C3792C3793C3796C37970076300070936500763000709372C4284C4294C4301C4354C437000763000709389C429500763000709396007630007094020076300070941900763000709426C424800763000709457C42980076300070946400763000709488C4205C4302C436300763000709518C4167C4222C4223C4224C4225C4285C4292C4303C4309C4362C4369C437400763000709532C4208C4209C4236C4245C4283C4286C4287C4288C4289C4290C4308C4310C4372C4373C437700763000709556007630007095700076300070959400763000709631C3884C3885C3907C3908C3909C3910C3911C3912C3913C3914C3915C3916C3918C3919C3920C3921C3922C3923C3924C3925C3926C3927C3928C3929C3930C3931C3932C3933C3934C3935C3936C3937C3938C3939C3940C3941C3942C3943C3944C3945C3946C3947C3948C3949C3950C3951C3953C3954C3955C3956C3957C3958C3959C3960C3961C3962C3963C3964C3965C3966C3967C3968C3969C3970C3971C3972C3973C3974C3975C3976C3977C3982C3983C3984C4014C4015C4016C4017C4018C4019C4020C4021C4022C4028C4045C4046C4047C4048C4049C4050C4051C4052C4053C4075C4076C4077C4078C4079C4080C4081C4082C4083C4084C4085C4086C4087C4089C4090C4093C4094C4095C4096C4097C4098C4100C4101C4102C4103C4104C4105C4106C4107C4108C4131C4132C4133C4134C4135C4136C4137C4138C4139C4140C4141C4142C4143C4144C4145C4146C4151C4152C4153C4154C4155C4156C4157C4158C4162C4163C4168C4169C4170C4171C4172C4173C4174C4175C4176C4177C4178C4179C4180C4181C4182C4183C4184C4185C4186C4187C4188C4190C4191C4193C4194C4195C4196C4197C4198C4199C4200C4210C4211C4212C4213C4214C4215C4217C4218C4219C4220C4226C4227C4228C4229C4230C4231C4232C4233C4234C4235C4237C4238C4239C4240C4241C4242C4243C4244C4246C4247C4251C4252C4253C4254C4256C4257C4258C4259C4260C4261C4263C4264C4265C4266C4267C4268C4269C4270C4271C4272C4273C4274C4278C4279C4281C4311

What the firm is doing

Medtronic notified consignees on about 05/19/2026 via "URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION" letter. Consignees were informed that affected systems may continue to be used prior to service by Medtronic to update the firmware. The issue is intermittent and may not present, however if it does it can be resolved by power cycling (rebooting) the system. A Medtronic Field Service Engineer will contact each facility to schedule time to update the firmware on each system to permanently resolve this issue. Consignees were instructed to complete and return the provided Customer Confirmation Form, provide the notification to all applicable personnel within the organization or to customers if product has been transferred, and to maintain a copy of the notice with their records.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Libya, Malaysia, Mexico, Morocco, Nepal, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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