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Terminated

Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top.

FDA Recall Z-0493-03 · Posted 2003-01-30

Recalling FirmSiemens Medical Systems Inc
Recall StatusTerminated
Product CodeIXR
Date Initiated2002-11-27
Date Terminated2005-01-10
Product Quantity13

Reason for Recall

There is unintended system movement or unwanted automatic movement of the tabletop.

Firm Action

Siemens personal will install Host Software VA00F and Generator Host Software VE00D on affected Uroskop units. Update instructions were sent to users November 27,2002 and December 7, 2002.

Root Cause

Other

Distribution Pattern

Product was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were distributed to Germany, Netherlands, Italy , Luxembourg, Sweden, Austria, Switzerland, Slovakia, Hungary, Ukraine, Russia, Turkmenistan, South Africa, Canada, Malaysia, Japan, and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923049UROSKOP D1, UROSKOP D2, AND UROSKOP D3Siemens Medical Solutions USA, Inc. · 1992-09-15

Official Source

View FDA Recall →

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

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