ClearanceBrief
Recall Z-0787-04 ยท JAK System, X-Ray, Tomography, Computed

Philips Medical Systems (Cleveland) Inc

Philips Brilliance CT Scanner System, 6, 10 & 16 slice images.

DateJul 20, 2004 (initiated Mar 8, 2004)
StatusTerminated
ReasonThe CT couch may move downward to its lower limit without command.
Root causeOther
ActionThe firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.
Quantity97 units
DistributionThe systems were installed at medical facilities located nationwide and worldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012009MX8000 IDT CT SYSTEM
Marconi Medical Systems, Inc., Sep 13, 2001