medical Class II Updated 2020-01-29

Palodex Group Oy recalls Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLA

Recalled Product

Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Hazard / Issue

Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

Issued by

FDA

Affected States: WI, PA
Lot/Code Info: Serial Number: TBD (range from IJ1208217 to IJ1313309) PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX
View official government recall

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