PlainRecalls
FDA Devices Moderate Class II Terminated

GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

Reported: August 29, 2012 Initiated: October 19, 2007 #Z-2221-2012

Product Description

GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

Reason for Recall

X-ray units did not meet manufacturer's specification for linearity.

Details

Units Affected
175 units
Distribution
Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada.
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.. Recalled by GE OEC Medical Systems, Inc. Units affected: 175 units.
Why was this product recalled?
X-ray units did not meet manufacturer's specification for linearity.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2221-2012.