Recalls / —
—#34884
Product
Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041
- FDA product code
- JAA — System, X-Ray, Fluoroscopic, Image-Intensified
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K960266
- Affected lot / code info
- Serial number: 3131.
Why it was recalled
X-ray tube movement when table is tilted more than 90 degrees
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- The products were shipped to medical facilities in FL, IL, MI, NH, NJ, PA, and TX.
Timeline
- Recall initiated
- 2004-06-07
- Posted by FDA
- 2004-09-18
- Terminated
- 2005-08-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34884. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.