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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
- 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