Recall Z-0196-05 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.
| Date | Nov 16, 2004 (initiated Sep 23, 2004) |
| Status | Terminated |
| Reason | Orbital gears may exhibit excess wear |
| Root cause | Other |
| 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. |
| Quantity | 82 units |
| Distribution | The product was shipped to medical facilities nationwide and government accounts in KS and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913120 | POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc., Aug 16, 1991 |