ClearanceBrief
Recall Z-0695-05 ยท LMB Device, Digital Image Storage, Radiological

Philips Medical Systems Sales & Service Region No. America

Easy Access Image Management System with CL.Net.

DateApr 8, 2005 (initiated Feb 16, 2005)
StatusTerminated
ReasonFailure to update correctly when re-transmitting an image from the modality.
Root causeOther
ActionThe firm mailed a letter on January 31, 2005, certified return receipt to their customers advising that a service representative will visit each site and install new software.
Quantity60
DistributionDevices distributed to hospitals and medical centers located throughout the U.S.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K983447WISE (II) IMAGE MANAGEMENT SYSTEM
Sectra-Imtec AB, Oct 29, 1998