ClearanceBrief
Recall Z-0563-03 ยท KPS System, Tomography, Computed, Emission

Philips Medical Systems Inc

Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.

DateFeb 21, 2003 (initiated Jan 23, 2003)
StatusTerminated
ReasonThe radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
Root causeOther
ActionThe firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.
Quantity311 units
DistributionThe sytems were shipped to end-users located nationwide and worldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K882312MODEL 3000 NUCLEAR CAMERA
Ohio Imaging, Inc., Jul 14, 1988