Product Wiki · Recalls · Health Canada — Medical Devices

O-arm O2 Imaging System (2018-10-14) — recall 58472

Health Canada — Medical Devices · Canada · 2018-11-15 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58472
Date of alert
2018-11-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Medtronic has developed a software update (SW version 4.1.0) that will address potential software issues/anomalies that resulted in unused X-Ray dose, delays in therapy (in all cases, of less than 1 hour), patient exposure to non-navigated surgery, and navigational inaccuracy. Medtronic has also received complaints associated with Mobile View Station (MVS) fuses within the ac power input circuit. This is resolved with the new design of the AC power input circuit. Medtronic will install the component(s) for the new AC power input circuit and IAS product label application and update the user manual.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/o-arm-o2-imaging-system-2018-1

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