Date of Enforcement Reporl: May 9,2001
Class: II
PRODUCT:
ISS 2001 X-Ray Imaging System. Recall # Z-246-1.
REASON:
The systems fail to conform to design specifications relating to the emission of
electronic product radiation.
MANUFACTURER:
Fischer Imaging Corporation,Denver, Colorado.
RECALLED BY:
Manufacturer, to supply new version (1.4) of software by May 1, 2002. Firm-
initiated recall ongoing.
DISTRIBUTION:
Nationwide.
QUANTITY:
27 units.
