Z-0515-2007

OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model...

Name: Z-0515-2007 OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model...
Creator: GE OEC Medical Systems, Inc
Published: 2007-01-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-01-15 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE... on 2007-01-15. The reason FDA records is "Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0515-2007
Status: Terminated
Initiated: 2007-01-15
Posted: 2007-02-15
Terminated: 2011-12-09
Recalling firm: GE Healthcare
Product: OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .
FDA root cause: Other
Action: Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.
Quantity in commerce: 277 units
Distribution: Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
Product codes and lots: Model Numbers 882082-01, 882082-02, 886765-01. Units with manufactured dates between 03/2003 and 08/2006.

Product code JAA

K993687Class IIUroview 2800Ge Dec Medical Systems / cleared 1999-12-21

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)