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Platinum (DRF) (2014-12-12)
- Starting date:
- December 12, 2014
- Posting date:
- January 28, 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-43465
Recalled products
- Platinum (DRF)
Reason
Apelem became aware of an incident during which the x-ray tube/collimator assembly became dissociated from its support, causing it to fall. The probable cause of the incident appears to be a fragility of the welding of the part M009G001 "Axe Support Tube", which can cause the part to break and cause the fall of the x-ray tube/collimator assembly.
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