ClearanceBrief
Recall Z-1223-03 ยท LLZ System, Image Processing, Radiological

Philips Medical Systems

Easy Access PACS System with software Release 5, 6.2, or 7.2

DateSep 12, 2003 (initiated Feb 13, 2002)
StatusTerminated
ReasonPotential display of an incorrect body part description on patient images.
Root causeOther
ActionOn 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.
Quantity46 units
DistributionThe firm distributed units to 46 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