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
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
Levo Arm - Component of the Levo Head Positioning System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
7887-050
Companies
- Manufacturer
-
Mizuho Orthopedic Systems, Inc.
30057 Ahern Avenue
Union City
94587-1234
California
UNITED STATES