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Platinum (DRF) (2014-12-11)
- Starting date:
- December 11, 2014
- Posting date:
- March 20, 2015
- 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-52573
Recalled products
- Platinum (DRF)
Reason
The X-Ray Tube / Collimator became dissociated from its support, causing it to fall out of position. The assembly was retained by the cables and there was no collision with the patient's support panel. The probable cause for the failure is the fragility of the welding of part M009G001 "Axe Support Tube".
Affected products
A. Platinum (DRF)
Lot or serial number
- C116F007
Model or catalog number
- 6F
Companies
- Manufacturer
-
Apelem SAS,
Parc Scientifique Georges Besse, 175,
Allée Von Neumann, F30035, Nîmes
30900
FRANCE