ClearanceBrief
Recall Z-0093-04 ยท LLZ System, Image Processing, Radiological

Philips Medical Systems (Cleveland) Inc

Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

DateNov 6, 2003 (initiated Sep 15, 2003)
StatusTerminated
ReasonDue to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
Root causeOther
ActionThe firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.
Quantity1,334 units installed
DistributionThe systems were installed at medical facilities located nationwide and worldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K003437ODYSSEY LX, MODEL 211320
Philips Medical Systems (Cleveland), Inc., Feb 2, 2001
K964712PRISM XPVT SYSTEM (210823)
Philips Medical Systems (Cleveland), Inc., Feb 21, 1997