Medtronic Navigation, Inc.-Boxborough — Class II: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Medtronic Navigation, Inc. has initiated a Class II recall for the O-arm O2 Imaging System (Model BI70002000) due to a firmware anomaly in the detector panel. This anomaly has the potential to cause image artifacts during use.
This affects Medtronic Navigation, Inc., healthcare facilities utilizing the O-arm O2 Imaging System, and clinical personnel responsible for intraoperative imaging and diagnostic quality.
The presence of image artifacts can compromise diagnostic clarity and intraoperative decision-making. Since the root cause is identified as a firmware anomaly, this highlight the risks associated with embedded software integrity in complex imaging hardware. Regulatory professionals should note that this remains an ongoing action, suggesting that mitigation or remediation steps may still be in progress.
QA and software engineering teams should verify the firmware version of on-site O-arm O2 units and ensure that internal CAPA processes address software-driven image quality risks. Regulatory teams should monitor for manufacturer updates regarding firmware patches or field corrections.
Class II. Reason: Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.. Product: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.. Firm: Medtronic Navigation, Inc.-Boxborough (Boxborough MA United States). Status: Ongoing.
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