ClearanceBrief
Recall Z-1125-03 ยท LLZ System, Image Processing, Radiological

Philips Medical Systems

Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

DateAug 12, 2003 (initiated Jun 27, 2003)
StatusTerminated
ReasonIf DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
Root causeOther
ActionOn 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.
Quantity46 devices
DistributionDevices were distributed to 23 hospitals and medical centers throughout the US.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

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