O-arm O2 Imaging System (2018-10-14)

Starting date:

October 14, 2018

Posting date:

November 15, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68216

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  Reason
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  Affected products

Affected products

O-arm O2 Imaging System

Reason

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.

Affected products