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Platinum (DRF) (2013-07-18)
- Starting date:
- July 8, 2013
- Posting date:
- October 16, 2013
- 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-36215
Recalled Products
Platinum (DRF)
Reason
A nonconformity of the Platinum X-Ray tube support shaft, has been observed on two devices (partial weld instead of a periferal weld bead), causing a risk of fragility of the weld, which could eventually break and cause fall of the X-Ray tube and collimateur 18.
Affected products
Platinum (DRF)
Lot or serial number
All lots
Model or catalog number
- 6F
Companies
- Manufacturer
-
Apelem SA
Rue Georges Besse
Allee Von Neumann, Nimes
30900
FRANCE