AXIOM Luminos dRF system or Luminos dRF Max 의 리콜

Recall

69067

Class 2

Z-2649-2014

2014-08-12

2014-09-16

Terminated

United States

2015-05-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129486

It was determined that a potential malfunction may occur on the luminos drf system with sw vd10 or on luminos drf max when the table side control is exposed to fluids. fluid may infiltrate the tableside control panel and result in malfunction. in the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the luminos drf / luminos drf max will automatically d.

Siemens sent a Customer Safety Advisory Notice XP045/14/S, dated August 12, 2014, to direct accounts, which identified the product, problem, and action to be taken to avoid potential risk to patients and users. Customers were instructed to avoid extensive exposure of fluids to the tableside control panel. When cleaning the system, customers were instructed not to appoly excessive fluids, only use damp towels, in accordance with the product manual. Customers were asked to forward the safety notice to any of their customers and to inform Siemens of the identify of the device's new owner where possible. For questions regarding this recall call 610-219-6300.