SensaVue (2020-03-18)

Starting date:

March 18, 2020

Posting date:

April 17, 2020

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-72791

Last updated: 2020-04-17

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  Reason
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  Affected products

Affected Products

SensaVue

Reason

The SensaVue DVI adapter does not have sufficient shielding to comply with requirements listed in IEC 60601-1-2 for electromagnetic emissions. The level of emissions is undetectable without specialized testing equipment and poses no risk to user or patient safety.

Affected products