Recalls / —
—#27914
Product
Cathcor/LX/Desktop, System, X-Ray, Angiographic
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K002137
- Affected lot / code info
- Serial Numbers:01029, 01033, 01034,01062, 01108, 01110, 01121, 01125, 02048.
Why it was recalled
Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
Root cause (FDA determination)
Other
Action the firm took
A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Parkway, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- 5 Hospitals/Clinics in the US.
Timeline
- Recall initiated
- 2002-11-27
- Posted by FDA
- 2003-07-19
- Terminated
- 2006-10-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #27914. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.