Z-0557-2007

OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System

Name: Z-0557-2007 OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System
Creator: GE OEC Medical Systems, Inc
Published: 2007-02-09
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-02-09 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System on 2007-02-09. The reason FDA records is "During routine service, a cover may have been installed without the required proper lead shielding". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0557-2007
Status: Terminated
Initiated: 2007-02-09
Posted: 2007-03-22
Terminated: 2007-06-26
Recalling firm: GE Healthcare
Product: OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System,
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: During routine service, a cover may have been installed without the required proper lead shielding.
FDA root cause: Other
Action: Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
Quantity in commerce: 11 units of all models
Distribution: Nationwide to AL, AZ, IA, OH, TX, VA, and WV.
Product codes and lots: Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.

Product code JAA

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)