Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466033
FDA device recall Z-1475-04 · posted 2004-09-18 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- X-ray tube movement when table is tilted more than 90 degrees
- Action taken
- The recalling firm issued a Customer DAfety Advisory letter dated 6/7/04 to the hospitals. The letter informs them of the potential problem and provides preventative measures to avoid its occurance.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 15 units
- Distribution
- The products were shipped to medical facilities in FL, IL, MI, NH, NJ, PA, and TX.
- Date initiated
- 2004-06-07
- Date posted
- 2004-09-18
- Date terminated
- 2005-08-18
- 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 |
|---|---|---|
| SIREGRAPH CF (K960266) | Siemens Medical Solutions USA, Inc. | 1996-03-11 |