Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0786-04

Philips MX8000 IDT CT Scanner System, 10 & 16 slice images

Philips North America LLC / initiated 2004-03-08 / Terminated

Philips Medical Systems (Cleveland) Inc began a recall of Philips MX8000 IDT CT Scanner System, 10 & 16 slice images on . The reason FDA records is "The CT couch may move downward to its lower limit without command". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0786-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.
Product code
JAK System, X-Ray, Tomography, Computed
Reason for recall
The CT couch may move downward to its lower limit without command.
FDA root cause
Other
Action
The 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.
Quantity in commerce
385 units
Distribution
The systems were installed at medical facilities located nationwide and worldwide.
Product codes and lots
Serial Numbers: 2501 to 2554; 3006; 3008 to 3337.