FDA-Device2015-08-19Class II

GE Optional Laser Centering Device X-ray generator.

GE Inspection Technologies, LP
Hazard

GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.

Sold states
US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
Affected count
25
Manufactured in
50 Industrial Park Rd, N/A, Lewistown, PA, United States
Products
GE Optional Laser Centering Device X-ray generator.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2015

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