Device Recall Siemens Luminos dRF, Ysio or Uroskop Omnia systems 의 리콜

Recall

68785

Class 2

Z-2292-2014

2014-07-07

2014-09-10

Terminated

United States

2015-02-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128661

It was discovered that during a rad examination using siemens luminos drf, ysio or uroskop omnia systems with software version vb10c to vb10f and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. this may also result in an overexposed image that is not of diagnostic quality. as a result the taken examination needs to be repeated. thi.

Siemens had informed all affected customers about this issue via Customer Safety Advisory Notice XP023/13/S (dated June 3, 2013) reported under C&R; # 2240869-05/16/13-0013-C. A corresponding software update to fix the issue was originally planned to be rolled out by May 2014. The originally scheduled roll out date could not be met and to ensure that this new software version works accurately Siemens incorporated a comprehensive monitoring phase. Siemens has now scheduled the roll out for the software version VB10J to be completed by end of October 2014. A letter, dated July 7, 2014, with important safety information was sent to end users to notify them that the new software version VB10J will be introduced to solve the potential malfunction of the generator.