FDA Recall Terminated

Uroview 2600 Uroview System

Recall: Z-0947-03 · Initiated May 12, 2003

Recall

Recall Number
Z-0947-03
Event Number
26383
Firm
GE OEC Medical Systems, Inc
FEI Number
1720753
Product Code
JAA
Status
Terminated
Root Cause
Other
Initiated
May 12, 2003
Posted
June 21, 2003
Terminated
July 7, 2011
Address
384 Wright Brothers Drive, Salt Lake City, UT, 84116

Description

Uroview 2600 Uroview System

Reason

Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.

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.

Distribution

Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.

Quantity

636 units