Recalls / —
—#162599
Product
Syngo.via. Medical Device Software. Picture archiving and communications system.
- FDA product code
- LLZ — System, Image Processing, Radiological
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K123375
- Affected lot / code info
- Model Number 10496180
Why it was recalled
A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Root cause (FDA determination)
Software design
Action the firm took
Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Timeline
- Recall initiated
- 2018-01-08
- Posted by FDA
- 2018-03-20
- Terminated
- 2020-04-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.