Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists
FDA device recall Z-0220-05 · posted 2006-02-14 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
- Action taken
- An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 921
- Distribution
- globally
- Date initiated
- 2004-12-30
- Date posted
- 2006-02-14
- Date terminated
- 2006-02-21
- 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 |
|---|---|---|
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |