Medical device recalls Moderate risk

GE Inspection Technologies, LP recalls GE Optional Laser Centering Device X-ray generator.

Recall date
November 10, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2320-2015
FDA classification
Class II
Brand / firm
GE Inspection Technologies, LP
Sold / distributed
US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Optional Laser Centering Device X-ray generator.

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