Levo Arm - Component of the Levo Head Positioning System (2019-10-21)

Starting date:

October 21, 2019

Posting date:

November 8, 2019

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-71551

Last updated: 2019-11-08

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  Reason
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  Affected products

Affected Products

Levo Arm - Component of the Levo Head Positioning System

Reason

Each of these packages includes a Levo Arm (7887-050) that provides the primary positioning and locking capabilities of the system. Recently, we became aware of the potential for fluid ingress resulting from unapproved cleaning techniques. Examples of incorrect cleaning could include submersion or exposure of the unit to direct fluid flow. This may result in fluid entering the unit, rendering the internal electronics inoperable and leading to a failure of the arm's locking mechanism in isolated situations.

Affected products