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Terminated

POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.

FDA Recall Z-0196-05 · Posted 2004-11-16

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2004-09-23
Date Terminated2005-01-25
Product Quantity82 units

Reason for Recall

Orbital gears may exhibit excess wear

Firm Action

The recalling firm issued Update Instructions, AX077/04/S, to Siemen''s Customer Service Representative (CSR) to visit affected sites and check the orbital gears for excessive wear. If the CSR finds gears exhibiting excessive wear the orbital gears will be replaced. If no wear is observed the gears will be lubricated as a preventive measure.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities nationwide and government accounts in KS and MI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K913120POLYSTAR ANGIOGRAPHIC X-RAY SYSTEMSiemens Medical Solutions USA, Inc. · 1991-08-16

Official Source

View FDA Recall →

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

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