Recalls / —
—#144261
Product
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
- FDA product code
- LLZ — System, Image Processing, Radiological
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K071114, K081734
- Affected lot / code info
- Model # 10014063
Why it was recalled
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Root cause (FDA determination)
Software design
Action the firm took
Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
Timeline
- Recall initiated
- 2016-01-18
- Posted by FDA
- 2016-04-07
- Terminated
- 2017-08-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144261. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.