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Terminated

Uroview 2500 X-ray System

FDA Recall Z-0946-03 · Posted 2003-06-21

Recalling FirmGE OEC Medical Systems,Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2003-05-12
Date Terminated2011-07-07
Product Quantity263 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K914446UROVIEW 2000, MODIFICATIONOec-Diasonics, Inc. · 1992-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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