ClearanceBrief
Recall Z-0640-05 ยท LLZ System, Image Processing, Radiological

Philips Medical Systems Sales & Service Region No. America

Xcelera R1.2 Cardiology image and information management solution software.

DateMar 18, 2005 (initiated Dec 21, 2004)
StatusTerminated
ReasonLoss of image data from image repository and archive requiring patients to undergo repeat imaging.
Root causeOther
ActionThe firm notified hospitals via letter sent 12/21/2004 stating the service organization will perform onsite upgrades.
Quantity33
DistributionHospitals and medical centers throughout the US.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022788PHILIPS HARMONY RELEASE 1
Philips Medical Systems North America Co., Oct 25, 2002