—#106410

Product

Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101666
Affected lot / code info: Model number 10592457, serial numbers 100174, 100177, and 100181.

Why it was recalled

The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.

Root cause (FDA determination)

Software design

Action the firm took

The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.

Timeline

Recall initiated: 2011-05-01
Posted by FDA: 2012-01-20
Terminated: 2014-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106410. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.