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Health product recall

ONDAL ACROBAT SPRING ARM (2015-08-04)

Starting date:
August 4, 2015
Posting date:
September 1, 2015
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-54852

Affected Products

  1. ONDAL ACROBAT SPRING ARM

Reason

TRUMPF Medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds in the front joint of spring arms over time when subject to extreme forces. TRUMPF Medical does not have complaints related to this failure mode. The supplier has advised that a visual inspection of the welded joints should be completed on a bi-annual basis (every two years) as advised in the user manual since July 2010. This inspection should therefore be occurring for all TRUMPF Medical surgical light, camera and monitor arm system, spring arms.

Affected products

ONDAL ACROBAT SPRING ARM

Lot or serial number

> 10 lot numbers, contact mfg

Model or catalog number
  • 1400191
  • 1441784
  • 1513140
  • 1528403
  • 1558932
Companies
Manufacturer
Trumpf Medical Systems
Inc.
1046 Legrand Boulevard
South Carolina
UNITED STATES