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Bluephase
- Starting date:
- August 14, 2012
- Posting date:
- February 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-20403
Recalled Products
A. Bluephase
Reason
In two cases to date, a very rare combination of swelling of the battery cell with a ridge on the inside plastic housing of the battery caused a chain reaction, allowing energy in the handpiece battery to be released, thus destroying the device and causing smoke damage.
Affected products
A. Bluephase
Lot or serial number
- 603752BU: 400000 to 400705
- 607920BU: 200000 to 221630
- 607921BU: 100000 to 103280
- 608532: 300000 to 300148
- 608535: 300000 to 302988
- 608535: 00001 to 024999
- 613735BU: 500000 to 504329
- 613753: 800000 to 800035
- 627300: less than 201500
Model or catalog number
- 607920BU
- 607921BU
- 608532
- 608535
- 613735BU
- 613752BU
- 613753
- 627300
Companies
- Manufacturer
- Ivoclar Vivadent AG