POLYSTAR, Angiographic X-Ray System, Model 1148902
FDA device recall Z-0195-05 · posted 2004-11-16 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Orbital gears may exhibit excess wear
- Action taken
- 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
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 43 units
- Distribution
- The product was shipped to medical facilities nationwide and government accounts in KS and MI.
- Date initiated
- 2004-09-23
- Date posted
- 2004-11-16
- Date terminated
- 2005-01-25
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM (K913120) | Siemens Medical Solutions USA, Inc. | 1991-08-16 |