Recalls / —
—#42537
Product
Sienet Cosmos. Radiological Image Processing. Model number 10018971
- FDA product code
- LLZ — System, Image Processing, Radiological
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K042832
- Affected lot / code info
- model number 10018971 version VB15C
Why it was recalled
reference lines appear above actual position
Root cause (FDA determination)
Other
Action the firm took
The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA.
Timeline
- Recall initiated
- 2005-09-22
- Posted by FDA
- 2005-10-28
- Terminated
- 2006-08-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #42537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.