Stander (Tilt Standing Frame) – Safety Warning Label Addition – For the Public

Starting date:

August 23, 2010

Posting date:

August 23, 2010

Type of communication:

Public Communication

Subcategory:

Medical Device, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Issue:

New safety information, Physical Hazard, Product Safety, Product label update

Audience:

General Public

Identification number:

RA-19000931

This is duplicated text of a letter from Rehabilitation Centre for Children.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication – Health Canada Endorsed Important Safety Information on Tilt Standing Frame

August 23, 2010

Subject: MEDICAL DEVICE RECALL - Safety Warning Label Addition

Serious injury may result if a Tilt Standing Frame is not used in accordance with the written use instructions. If an individual on the frame is moved to an upright position without the safety straps, knee blocks and tray in place, the individual may fall forward, tipping the Tilt Standing Frame and posing a risk of serious injury.

• The Tilt Standing Frame must be used with all supplied safety straps, knee blocks and tray in place.
• Obtain supplemental warning labels and place them on any Tilt Standing Frame in order to remind users that the straps, knee blocks and tray have to be in place before lifting a patient.
• Individuals should never be left unattended while in the Tilt Standing Frame.

Tilt Standing Frames are dispensed with written use instructions, which must be followed at all times when using the unit.

Supplemental warning labels have been developed by the Rehabilitation Centre for Children for placement on the Tilt Standing Frame. These labels state: "Stop. Ensure the straps, knee blocks and tray are in place before lifting, or injury may result."

If you require a copy of the written use instructions, to obtain the supplemental warning labels or for any further information, please contact the Assistive Technology Clinic at the Rehabilitation Centre for Children at 204-453-9822, or toll-free at 1-866-314-0501.

All Tilt Standing Frames in production will be dispensed with the supplemental labelling in place.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of falls, serious injury or other serious or unexpected adverse incidents in patients using the Tilt Standing Frame should be reported to the Rehabilitation Centre for Children or Health Canada at the following addresses:

Rehabilitation Centre for Children
633 Wellington Crescent
Winnipeg, MB
R3M 0A8
Telephone: 204-453-9822, Toll Free 866-314-0501

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Sincerely,

original signed by

Mike Forbes
Director,
Mechanical Design & Development
Rehabilitation Centre for Children