Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device 의 리콜

Recall

34955

Class 2

Z-0533-06

2006-02-23

2006-03-29

Terminated

United States

2012-02-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45009

When the error condition occurs the x-ray exposures will terminate immediately. the digital system (eps-plus/adr-1000a) will immediately stop acquiring images or will continue to acquire blank images. the remote console will lock-up upon release of the hand switch. the operator must reboot the system. this will result in the loss of the images acquired during the contrast portion of the study.

Recall letter to be sent to to customers of affected devices beginning February 23, 2006. Corrected software to be issued by Toshiba America Medical Systems Inc, for all affected devices.