Ellex Solo-A (2020-04-03)

Starting date:

April 3, 2020

Posting date:

May 1, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72941

Last updated: 2020-05-01

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  Reason
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  Affected products

Affected Products

Ellex Solo-A

Reason

Defect in the joystick wiring. There is the potential that the insulation of the wire can become compromised, potentially causing the exposed conductor to come into contact, with the grounded metal housing. As an outcome when the system is in the "ready" mode, an unintended laser emission may result.

Affected products