ClearanceBrief
Recall Z-0100-04 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified

Toshiba American Med Sys Inc

Digital Fluorographic System model DFP-2000A.

DateNov 6, 2003 (initiated May 27, 2003)
StatusTerminated
ReasonImages display with wrong patient demographics.
Root causeOther
ActionFirm has issued to it''s service persons orders to install a software fix on 27 May 2003.
Quantity471
DistributionNaitonwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K941611TDA-4000/A4
Toshiba America Medical Systems, In.C, May 13, 1994