Reported Aug 19, 2015 · Terminated

GE Optional Laser Centering Device X-ray generator.

GE Inspection Technologies, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Inspection Technologies, LP · 50 Industrial Park Rd · Lewistown, PA · 17044-9312

Is this the product you have?

  • GE Optional Laser Centering Device X-ray generator.
Lot codes and dates
  • Model No. 025.03.00A
Amount recalled
25

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 1, 2017 · Data as of Sep 19, 5:29 PM UTC

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