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Focus Dental X-ray System (2014-01-14)
- Starting date:
- January 14, 2014
- Posting date:
- December 18, 2014
- 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-42949
Recalled Products
Focus Dental X-ray System
Reason
An internal investigation at Palodex revealed that wall mounting units that were missing structural welds had been delivered to Palodex by the supplier. It was determined that the defective wall mounting units could potentially cause a safety hazard, if the top weld is missing and wall mounting unit fails to support the device.
Affected products
Focus Dental X-ray System
Lot or serial number
F21221 TO F21643
Model or catalog number
50600
Companies
- Manufacturer
-
Palodex Group OY also trading as Instrumentarium Dental,
Nahkelantie 160,
Tuusula,
04300
FINLAND