Recalls / —

—#35303

Product

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

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K913120

Affected lot / code info

Serial Numbers for model 1148902: 01000 through 01267, 02001 through 02117. Serial numbers for model4784505: 03001 through 035158, 04001 through 04136, and 05001 through 05098

Why it was recalled

Orbital gears may exhibit excess wear

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

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

Timeline

Recall initiated

2004-09-23

Posted by FDA

2004-11-16

Terminated

2005-01-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.