Z-0678-2007

OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT

Name: Z-0678-2007 OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT
Creator: GE OEC Medical Systems, Inc
Published: 2007-03-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-03-01 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT on 2007-03-01. The reason FDA records is "During routine service, primary and/or secondary collimators may not have been properly reinstalled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0678-2007
Status: Terminated
Initiated: 2007-03-01
Posted: 2007-09-28
Terminated: 2012-05-01
Recalling firm: GE Healthcare
Product: OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
FDA root cause: Other
Action: Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
Quantity in commerce: 17 units
Distribution: Nationwide and Germany.
Product codes and lots: Serial Numbers: FIB-0020, FIB-0025, FIB-0038, FIB-0050, FIB-0065, 2799PU5, 2832PU4, 3380PU3, 3589PU9, 4037PU8, 4816PU5, 4842PU1, 4860PU3, 5190PU4, 5204PU3, 5210PU0, 5270PU6.

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)