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Twin Coil
- Starting date:
- May 9, 2017
- Posting date:
- June 5, 2017
- 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-63486
Reason
The coil housing broke apart due to a breakdown in the coil winding element inside the housing. The breakdown occurred near the outlet from the outer winding. The breakdown had been initiated from mechanical stress near the outlet. Such breakdown can start in the wires that are bended or twisted. During stimulation some mechanical displacement/movements will occur inside the litze wire and between the windings.
Affected products
Twin Coil
Lot or serial number
Serial number: 1023
Model or catalog number
9016E0691
Companies
- Manufacturer
-
Tonica Elektronik A/S
Lucernemarken 15
Farum
3520
DENMARK