Recall Z-2221-2012— GE OEC Medical Systems, Inc

Name: FDA recall Z-2221-2012
Creator: U.S. Food and Drug Administration
Published: 2007-10-19

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2007-10-19, terminated 2012-08-17. It names one FDA 510(k) clearance: K003837. Product: GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.. Reason: X-ray units did not meet manufacturer's specification for linearity..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2007-10-19
Terminated: 2012-08-17
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K003837 — FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems·cleared 2001-03-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.