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Terminated

Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.

FDA Recall Z-0306-04 · Posted 2004-01-08

Recalling FirmGeneral Electric Med Systems
Recall StatusTerminated
Product CodeIYB
Date Initiated2003-12-08
Date Terminated2005-11-15
Product Quantity400

Reason for Recall

Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.

Firm Action

Field Modification Instructions (FMI''s) will be issued to the field to inspect and locate suspect tubes and replace any that may be susceptible to failure.

Root Cause

Other

Distribution Pattern

Distributed nationwide throughout the US and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023988GE DISCOVERY LS SYSTEMGE Medical Systems · 2003-02-04K013561LIGHTSPEED 4.0 CT SCANNER SYSTEMGE Medical Systems · 2001-11-08

Official Source

View FDA Recall →

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

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