FDA recall Z-2777-2017

Product

GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

Reason for recall

GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.

Distribution

US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore

Key facts

Status

Terminated

Initiation date

2017-06-28

Report date

2017-08-09

Termination date

2020-02-06

Voluntary/Mandated

FDA Mandated

Location

Lewistown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2777-2017