ClearanceBrief
Recall Z-0888-05 ยท LNH System, Nuclear Magnetic Resonance Imaging

Hitachi Medical Systems America Inc

Hitachi Altaire Magnetic Resonance Imaging Device.

DateJun 14, 2005 (initiated Jun 30, 2005)
StatusTerminated
ReasonImage reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
Root causeOther
ActionThe recalling firm is sending recall letters to all consignees.
Quantity177 devices
DistributionThe product was distributed throughout the United States and to one consignee located in both Wales and London.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K002420HITACHI ALTAIRE
Hitachi Medical Systems America, Inc., Oct 17, 2000
K022390HITACHI ALTAIRE
Hitachi Medical Systems America, Inc., Oct 11, 2002