Company: Analogic Corportation
Date: 6/13/01
Class: II
PRODUCT:
a) Philips Tomoscan M. Recall # Z-550-1.
b) Philips Tomoscan EG. Recall # Z-551-1.
c) Philips Tomoscan EG. Recall # Z-552-1.
REASON:
The diagnostic x-ray devices fail to conform to design specifications relating to the accomplishment of their intended purpose.
CODE:
a) Philips Tomoscan M; b) Philips Tomoscan EG;
c) Philips Tomoscan EG Compact.
MANUFACTURER:
Analogic Corportation, Peabody, MA.
RECALLED BY:
Manufacturer representative will replace the current CT control software with a software version 4.0 by July 31, 2001. Recall ongoing.
DISTRIBUTION:
U.S. and worldwide.
QUANTITY:
48 units in the US, 367 units Worldwide.
