Z-0947-03

Uroview 2600 Uroview System

Name: Z-0947-03 Uroview 2600 Uroview System
Creator: GE OEC Medical Systems,Inc
Published: 2003-05-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2003-05-12 / Terminated

FDA source

GE OEC Medical Systems,Inc began a recall of Uroview 2600 Uroview System on 2003-05-12. The reason FDA records is "Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0947-03
Status: Terminated
Initiated: 2003-05-12
Posted: 2003-06-21
Terminated: 2011-07-07
Recalling firm: GE Healthcare
Product: Uroview 2600 Uroview System
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
FDA root cause: Other
Action: A Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units.
Quantity in commerce: 636 units
Distribution: Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
Product codes and lots: Serial numbers beginning with W2 and W9.

Product code JAA

K940295Class IIUroview Model 2600Ge Dec Medical Systems / cleared 1994-08-22

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)