Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
FDA device recall Z-0306-04 · posted 2004-01-08 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems
- Reason for recall
- Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYB
- Quantity affected
- 400
- Distribution
- Distributed nationwide throughout the US and worldwide.
- Date initiated
- 2003-12-08
- Date posted
- 2004-01-08
- Date terminated
- 2005-11-15
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DISCOVERY LS SYSTEM (K023988) | GE Medical Systems | 2003-02-04 |
| LIGHTSPEED 4.0 CT SCANNER SYSTEM (K013561) | GE Medical Systems | 2001-11-08 |