Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Published: June 24, 2026Recall ID: Z-2451-2026Category: devicesCountry: US

Reason for Recall / Hazard

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

Field	Value
City	Boxborough
State	MA
Event id	99041
Address 1	200 Beaver Brook Road
Code info	Model Number: BI70002000. GTIN (Serial Numbers): 00643169639683 (C1640), 00643169651814 (C3815, C3816, C3817, C3818, C3891, C3898, C3899, C3900, C3901, C3902, C3903, C3905, C3990, C3997, C3998, C3999, C4001, C4002, C4003, C4004, C4059, C4060, C4061, C4062, C4063, C4064, C4065, C4066, C4067, C4068, C4116, C4117, C4118, C4119, C4120, C4121, C4122, C4123, C4130, C4201, C4202, C4203, C4356, C4357, C4360, C4361), 00763000132378 (C2096, C2187), 00763000355555 (C2768), 00763000481599 (C3895, C3996), 00763000496586 (C3794, C3896, C4023, C4031, C4032, C4043, C4088, C4092), 00763000496593 (C3887, C3889, C3978, C3988, C3991, C3994, C4041, C4109, C4110, C4111, C4161), 00763000496609 (C3802), 00763000496630 (C4035), 00763000496647 (C4012, C4126, C4129), 00763000496661 (C3824, C3987, C4071, C4072), 00763000496678 (C3879), 00763000496692 (C3799, C3823, C3897, C3979, C4027, C4037, C4044, C4125), 00763000496708 (C3825), 00763000496715 (C4074, C4128), 00763000496722 (C3812, C3822, C3828, C3881, C4034, ... [TRUNCATED]
Postal code	01719
Report date	20260624
Product type	Devices
Product quantity	589 units
Reason for recall	Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20260519
Initial firm notification	Letter
Center classification date	20260615

Recalling FirmMedtronic Navigation, Inc.-Boxborough
StatusOngoing
Risk LevelClass II
DistributionWorldwide 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.