Siemens syngo.plaza 의 리콜

Recall

65792

Class 2

Z-0271-2014

2011-08-08

2013-11-13

Terminated

United States

2014-11-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120166

The firm became aware of an unintended behavior when using the syngo.Plaza. the "rename" functionality can cause an unintended patient merge if the patient is sent to another system. this issue affects customers who transfer patient data between two or more syngo.Plaza or syngo imaging xs systems.

Siemens sent a Customer Safety Advisory Notice dated August 3, 2011, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to forward the Customer Safety Advisory Notice to their customers. If necessary, customers should have the letter translated technically into the local language and copy it themselves. A letter was sent to direct accounts to inform them of the issu and provide instructions to avoid encountering the problem. For questions regarding this recall call 610-219-6300.