Z-0850-2007

GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah

Name: Z-0850-2007 GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah
Creator: GE OEC Medical Systems, Inc
Published: 2007-06-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-06-12 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah on 2007-06-12. The reason FDA records is "X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0850-2007
Status: Terminated
Initiated: 2007-06-12
Posted: 2007-06-30
Terminated: 2011-11-01
Recalling firm: GE Healthcare
Product: GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
FDA root cause: Other
Action: Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.
Quantity in commerce: 22 units
Distribution: Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.
Product codes and lots: Serial Numbers: 7315PU5, 7372PU6, 7384PU1, 7385PU8, 7389PU0, 7390PU8, 7393PU2, 7398PU1, 7398PU1, 7399PU9, 7702PU4, 7720PU6, 7721PU4, 7724PU8, 7725PU5, 7726PU3, 7728PU9, 7729PU7, 7732PU1, 7733PU9, 7734PU7.7747PU9.

Product code JAA

K003837Class IIFlexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems / cleared 2001-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)