Seneographe 800T Mammography X-Ray Systems
FDA device recall Z-0285-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems
- Reason for recall
- The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
- Action taken
- The consignees were sent 'Regulatory Notice' letters dated February 6, 2004. The letters informed the consignees of the violations and provided them with the technical specifications which needed to be provided.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZH
- Distribution
- Nationwide in the United States
- Date initiated
- 2004-02-06
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-23
- 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 |
|---|---|---|
| SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE (K953250) | GE Medical Systems | 1996-01-26 |